posted 1/25/2012

Amcor is a global leader in responsible global packaging solutions supplying a broad range of plastic (rigid & flexible), fiber, metal and glass packaging products to enhance the products consumers use in everyday life. Amcor also provides packaging related services that help customers succeed through collaboration and innovation driven by art and science.

We are searching for a Quality Technician at the Des Plaines, IL location. To be considered, apply online at https://www.amcorrpjobs.com/apply/default.aspx  . Please no outside agencies.

Job Purpose

Quality Assurance Technicians provide overall front-line support to the production of quality injection and blow mold product with an overall understanding of visual inspection using various lab equipment and methods.  Qualified candidates must have an overall understanding of the Injection and Blow mold processes; ability to understand & follow basic testing practices & guidelines; ability to perform measurements & testing on lab equipment provided.

Job Duties & Responsibilities:

·         Promote and follow all corporate and local OSHE and Quality policy and guidelines

·         Follow all corporate and local policy, procedures, and guidelines

·         Follow all job specific SOP’s, Work Instructions, and NON SOP’s

·         Follow all cGMP and GDP practices

·         Collect and evaluate Injection and Blow mold product by using various inspection techniques and equipment

·         Properly report findings and actions taken to ensure that customer specifications are met.  This includes communicating effectively any quality deviations to internal and external customers in a timely manner according to Company policy

·         Communicates effectively verbally & in writing with customers (both internal & external) regarding quality issues

·         Alert Management of potential quality problems to assure that defective product or raw materials are not used or shipped to the customer

·         Has the authority to stop machines / production & communicate issues effectively to QA Manager

·         Perform timely inspection of all incoming materials, purchased or sample materials, in-process materials, reworked materials and finished goods through the use of visual inspection, sampling, SPC and laboratory instrumentation

·         Demonstrates organizational ability to complete daily assignments as required to meet internal and external customer requirements in a concise detailed manner

·         Provide training to employees in other departments regarding quality as needed

·         Enter required data on-line with minimal errors

·         Audit and maintain accurate records for product capability and traceability.

·         Perform containments, visit customers and monitor production as needed

·         Follows all established safety rules and guidelines as outlined in the Amcor Employee Handbook and as trained.  Understands and communicates all hazards and safety issues to co-workers and Supervisors.  Properly uses all required personal protective equipment

·         Understands SPC & is able to interpret quality data and statistics

·         Applies and enforces Good Manufacturing Practices & HACCP requirements to meet plant goals

·         Demonstrate organizational ability to complete daily clean-up assignments, and adequately maintain good housekeeping throughout the entire area of responsibility.

·         Directly responsible for the proper support to the Machine Operators and all other team members to ensure a positive team environment.   

·         Performs other related duties as directed by the Quality Assurance Manager

·         Performs troubleshooting, calibration & maintenance of Lab / inspection equipment

·         Train other employees in areas of expertise when required

·         Assists other job classifications when required

Perform other functions as assigned by supervision

Job Requirements:

·         Requires a High school diploma or equivalent. Some post secondary education preferred (i.e., Technical or Vocational Education)

·         Previous quality assurance or manufacturing work experience in plastics industry is preferred

·         American Society for Quality (ASQ) Certified Quality Technician preferred. If the candidate does not have a certification, must be able to get a certification within a year

·         Ability to work all shifts and required overtime

·         Ability to recognize & understand numbers & values and enter this information into an online database accurately. A strong Mathematical ability is essential

·         English literacy with excellent verbal and written communication skills 

Basic math, computer, and organizational skills

posted 1/25/2012

Advanced Web

(EEO/AA Employer)

Position Description

Job Title:                                            Quality Systems Specialist

Department:                                      Quality

Supervisor:                                       Quality Director

Indirect Reporting, if applicable:    Vice President, Operations

NOTE: Position is for the facility located in Elgin, Illinois

General Description of Job:

To assist in developing and maintaining the quality management system at US Converting, which ensures achievement of established quality objectives and ensures environmental management requirements are met at US Converting.

Primary Tasks and Responsibilities (Note, activities that occupy approx. 80% of time):

§         To maintain quality processes and records;

§         To assist in maintaining improvement programs;

§         Maintain and update documentation and quality documents to meet standards.

§         Perform internal audits;

§         Inspecting product (as needed); first article inspection; geometric dimensioning and tolerance a plus.

§         Creating standard and periodic quality reports for other departments;

§         Supporting quality at the source (production), sales and planning personnel;

§         Providing improvement feedback to quality director

§         Sustain 5-S within the department; assist others;

§         Maintain customer quality requirements and programs (such as food safety requirements) within US Converting.

§         Maintain Quality Hold Area; member of material review board.

§         Communicate with suppliers and customers regarding complaints.

§         Assist Production Manager with safety program compliance.

Secondary Tasks and Responsibilities (Occupies balance of time):

§         Any other activities that relate to quality as requested by the Quality Director;

§         Participate in quality improvement initiative to ensure customer satisfaction and that all jobs meet or exceed estimated time and materials; lean manufacturing;

§         Assist and/or escort customers that wish to perform audits at Advanced Web; maintain and expedite tools within the calibration program;

§         Facilitate training classes as requested;

Physical Job Demands:

This position will be expected to lift at least 30 lbs. due to product inspections and that may require moving and repackaging.  Walking amongst and observing production processes will be required.  Able to stay level headed and calm in stressful situations; able to tolerate high to moderate noise (example: pressroom machines/manufacturing plant noise).

Skills/Abilities to Meet Job Requirements:

Ability to write structured reports relating to quality issues and improvement projects; ability to create and organize electronic files for calibration, audits, and food safety programs; ability to take direction and accomplish projects in a timely manner; ability to perform multiple tasks and understand priorities; proficiency with Word and Excel; Visio flowchart program skills; purchase order requisition, review skills; web-savvy.

Education and Experience Requirements:

Required: High School diploma – OR equivalent GED; standardized quality assurance experience; manufacturing experience – minimum of 3 years;

Preferred: Auditing experience; ISO-9001-2008 or Six Sigma experience; AIB or Safe Quality Food systems experience, lean manufacturing techniques are a plus.

Method to Measure Performance:

Employee must complete the training/orientation period (usually 90 days).  Weekly meetings with quality director to report on status of tasks; evaluated at 6 months and one year, and thereafter at annual review.

To apply, please send resume to : nolson@advancedweb.com

Confidentiality assured. Thank you for your consideration!

posted 1/25/2012

Catalent Pharma Solutions - Position Description

Reports to: Quality Manager  

             Location: Woodstock, IL        

Catalent is a leading provider of advanced technologies and outsourced services for the pharmaceutical, biotechnology and consumer health industry. Catalent develops, manufactures and packages pharmaceutical and other products for customers in nearly 100 countries, employs approximately 9,000 at more than 30 facilities worldwide and generates more than $1.7 billion in annual revenue. Among its core offerings, develops and manufactures oral and sterile pharmaceuticals in nearly all major dosage forms, and offers proprietary technologies used in many well-known prescriptions and over-the-counter products.  Catalent is also the largest contract packager of pharmaceuticals.

The Compliance Specialist position is responsible for overseeing and providing metrics for all supplier audit and internal audit and change control programs. The Compliance Specialist is also responsible for providing metrics for Corporate Review, Management Review, and Annual Product Reviews. In addition, the position is responsible for providing training related to CAPA, Change Control, Quality Management Review, Supplier Audit and Internal Audit programs.

·         Directly responsible for performing all Quality functions for the supplier and Internal Audit process which include:

o        Scheduling and conducting supplier and internal audits.

o        Evaluation of the adequacy of audit responses related SOPs and their compliance to the regulatory requirements

o        Review of implemented audit responses for completeness, accuracy, and compliance to cGMPs and SOPs

o        Supervise the timely implementation of audit tasks

o        Distribute closed audit tasks to central file

o        Provide audit readiness training

o        Provide training on How to Conduct and Investigation and Root Cause Analysis

·         Directly responsible for providing metrics for Corporate Review, Management Review, and Annual Product Reviews

·         Directly responsible for performing all Quality functions for the CAPA process which include:

o        Evaluation of the adequacy of CAPA related SOPs and their compliance to the regulatory requirements

o        Review of implemented CAPAs for completeness, accuracy, and compliance to cGMPs and SOPs

o        Supervise the timely implementation of CAPAs

o        Distribute Closed CAPA PRs to central file

o        Reassign CAPA PRs, as applicable

o        Conduct Regularly scheduled meetings with each area to track CAPA progress – includes maintaining agendas and meeting minutes

o        Provide training on CAPA Quality System in Track Wise

·         Performing Change Control activities including:

·         Directly responsible for coordinating and conducting Management Review which includes:

o        From establishing an agenda to maintaining final presentation, minutes, and certification statement

·         Ability and willingness to actively participate in the resolution of issues (documentation or process)

·         Provide data for customer and Regulatory audits, as applicable

·         Maintain effectiveness of the Quality System.

·         Other duties as assigned.

Education or Equivalent:

·         Bachelor of Science in a science field or equivalent experience

Experience: 

·         Minimum of 3 years experience performing supplier and internal audits

·         Minimum of 3 years of QA experience in a cGMP/GLP environment

Knowledge/Skills Requirements: 

·         Demonstrated intermediate mathematical ability.

·         High level of attention to detail.

·         Excellent documentation skills.

·         Strong communication skills both written and oral.

·         A full complement of business computer literacy skills (e.g., word processing, spreadsheets, database software etc.) is preferred.

·         Strong problem solving and analytical skills.

·         Must possess strong communication skills allowing direct interaction with STW internal Managers and Sr. Management.

·         Ability to work independently on multiple projects.

·         Works well in a team environment.

·         Works well under pressure and able to prioritize workloads.

·         Must be able to interact effectively with a variety of individuals and personalities within and between departments.

·         Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.

·         Review reports, etc. for accuracy and logic.

·         Must be able to perform risk assessments in a timely manner and act accordingly. 

·         Should be familiar with cGMP, GDP and safe work practices.

·         Be organized.  Maintain good records, and be able to access them rapidly.  Understand where information can be found.

·         Demonstrated ability to read, write, and speak clear English.

Physical Requirements: 

·         Frequent sitting, standing, walking, reading of written documents and use of computer monitor screen, reaching with hands and arms, talking, writing, listening

·         Occasional bending, grasping, climbing ladders/steps, carrying, stooping, kneeling, crouching

·         Frequent lifting and/or moving up to 10 pounds and occasional lifting and/or moving up to 30 pounds

Business Environment: 

 ·         Fast-paced

·         Travel expected up to 30% to supplier sites

·         Performance driven

·         Customer focused

·         Collaborative and inclusive

 Tiffany Thompson, PHR
Recruiter, Talent Acquisition
Catalent Pharma Solutions
160 Pharma Drive, Morrisville, NC 27560
Direct: (919) 465-8070 | Mobile: (919) 539-1694

posted 1/25/2012

Manpower Professional – Elgin IL                                    

tim.leigh@manpower.com

Job Description 

 Are you a Quality Engineer looking for a new career, one where you can offer your unique skills and experiences? Manpower Professional can offer something unique for you. We are the place for talented individuals who want to do things differently, get ahead and establish a lifelong career. Manpower Professional is currently recruiting for a contract-to-hire position in Elgin IL for a Quality Engineer working primarily with touch screen technology.

You are precision-oriented, intuitive and a stickler for doing it right. You are in your element when you are working with anything mechanical or electrical. You are a whiz at keeping things operating at peak performance. You follow directions perfectly, but can also determine appropriate solutions on your own. If this describes you, you will want to learn more about this opportunity from Manpower Professional!

In this Quality Engineering position, you willl have the opportunity to:

-          Use your expertise to troubleshoot and resolve product errors

-          Develop innovations in quality and efficiency in current operation processes

-          Oversee training and progress of quality processes

-          Work with cross functional teams on new product development

Are you interested? The ideal Quality Engineer candidate will possess:

-          BSBA in Engineering or a technical field or equivalent experience

-          Ability to work independently and in a team environment

-          Demonstrated problem solving and root cause analysis skills

-          Must have knowledge of EMI, EMR and Power Supply

You can see it. More challenging work. A more interesting work environment. The opportunity to use your finely honed skills to make a real difference. And to collect pay that reflects your talent and expertise. If this is what you see for yourself, you need to talk to Manpower Professional.

Besides gaining valuable experience with some of the most reputable organizations in the market, you’ll gain access to Manpower Professional comprehensive benefits package.

We offer all the advantages you would expect from an industry leader, including a competitive salary, comprehensive health benefits, paid time off, training and much more.

We’ve got the right opportunity. Tell us why you’re the right person! Apply today.

Please email your resume to tim.leigh@manpower.com.

posted 1/25/2012

Manpower Professional – Elgin IL                                    

tim.leigh@manpower.com

Job Description 

Quality Engineer/Manager - You’ve imagined it many times. You’re working at a company that challenges you to innovate and encourages you to apply your talent and knowledge. Where you’re empowered and expected to make decisions that propel business growth. Where you receive compensation worthy of your sterling accomplishments. If that’s your vision, but not your current reality, Manpower Professional has a career opportunity for you. Only local applicants will be considered for this position.

We are currently looking for an experienced Quality Engineer/Manager for a long-term position with a growing company in the Elgin area. This position will give you the opportunity to work in a hands on environment in for an established and successful company, leading the way and innovating processes with your good ideas and industry expertise. This position requires a strong background in Quality Engineering in a manufacturing environment.

If you could design your perfect position, what would you include? The opportunity to use your skills and experience fully? To make a strategic contribution? Rewards and recognition for your contributions? Growth potential?

• Competitive salary that matches your drive and energy
• Comprehensive benefits
• The advantages of working with an industry leader who understands the importance of life/work balance
• Opportunities for career advancement and professional growth

In this Quality Engineer/Manager position, you'll have the opportunity to:

• Drive solutions to unique problems through troubleshooting expertise and root cause analysis
• Continuously improve current processes and develop new time and cost saving systems
• Use your attention to detail to ensure the highest quality product is being delivered to the customer
• Communicate with multiple departments and cross functional teams

Are you interested? The ideal Quality Engineer/Manager candidate will possess:

• Bachelor Degree in Engineering or technical field
• Established working history in applicable field
• Must have experience using measurement tools and working knowledge of metrology
• Strong attention to detail and independent work ethic

You can see it. More challenging work. A more interesting work environment. The opportunity to use your finely honed skills to make a real difference. And to collect pay that reflects your talent and expertise. If this is what you see for yourself, you need to talk to Manpower Professional.

Besides gaining valuable experience with some of the most reputable organizations in the market, you’ll gain access to Manpower Professional comprehensive benefits package.

We offer all the advantages you would expect from an industry leader – including a competitive salary, comprehensive health benefits, paid time off, training and much more.
We've got the right opportunity. Tell us why you're the right person! Apply today!

Please email your resume to tim.leigh@manpower.com.

posted 1/25/2012

DIAGEO NORTH AMERICA

The Plainfield Operation has a diverse product offering, ranging from PAB to white spirits to ready-to-drink cocktails. This product mix requires a wide range of testing and analysis to ensure that the products are produced to Diageo's high quality standards.   The Quality Team is responsible for supporting the Production Team in ensuring that Diageo's products are produced in compliance with TTB and Company regulations, and that these products meet the expectations of our discerning consumer base.   This role as part of the Quality Team will play a key role in delivering on the quality commitments of the organization in ensuring that Diageo's high standards are maintained. This role will be on the night shift.

Purpose of Role

As a member of the plant quality team, the Quality Technician is responsible for ensuring that production maintains the established standards and quality control systems outlined by Diageo to safely produce quality cases of our various distilled products that meet Diageo's commercially accepted criteria. As a vital member of the team, this specific position will focus primarily on:

• Providing quality leadership on the shift

• Performing microbiological testing of water, distilled products and ingredients.

• Performing process audits to monitor compliance to Global Risk Management and North American Standards

• Performing inspections of raw materials to ensure conformance to product specifications

• Performing sensory analysis of in process products, finished products and ingredients

• Performing analytical testing on in process products, finished products and ingredients to ensure adherence to product specifications

Complexity of Role

This position will work closely with the other shift Quality Technician and Operations Team Members to support in the accurate analysis of our products and ingredients through the use of testing equipment. This will require them to be able to quickly analyze a problem and provide timely remedies to ensure a continuous flow of production. The ability to multi-task and prioritize their workload is critical to being successful in this role. As a secondary function, they will be expected to gain an understanding of the calibration, maintenance and basic repair of the testing equipment utilized for quality analysis in the laboratory and in production. They will also be expected to contribute their technical expertise to solve problems for the plant operations and participate in cross-functional work-teams.

Outputs/Deliverables

Deliver on Quality objectives as assigned

Perform microbiological testing and analysis in accordance with Company defined protocols for submitted samples to support plant operations

Test instrumentation methods and results to insure appropriate accuracy

Ensure delivery of all License to Operate and other company deliverables

Experience

Degree/Diploma in Chemistry, Microbiology or Engineering preferred or 3-5 years of analytical experience in a laboratory or in a plant environment

Ability to analyze issues and provide logical resolutions

Strong communication and writing skills

Strong organization skills

Ability to multi-task

Familiarity with HPLC, spectrophotometer, alcolyzer and other equipment used in analysis of distilled products and ingredients is a plus

Familiarity with performing distillations and/or microbiological test methodology is a plus.

Carin Dupuis
Manager, Talent Research Acquisition
DIAGEO
(203) 229-4744 (O)
(203) 809-7223 (C)
(203)845 5969(F)
Carin.Dupuis@Diageo.com

http://www.linkedin.com/in/carindupuis

CHECK OUT OUR CAREER WEBSITE AT: http://www.diageo-careers.com/Pages/home.aspx

www.youtube.com/user/DiageoCareers

posted 1/25/2012

Position: Quality Engineer - #46594

Type: Direct

Location: Woodridge, IL 

POSITION OVERVIEW:

The Quality Engineer position has responsibility for conceiving, developing, monitoring, and controlling quality specifications. This is accomplished by proactively establishing and documenting requirements, as well as collecting and evaluating data. The QE must be able to coordinate customer, supplier, and internal manufacturing issues.

ESSENTIAL FUNCTIONS:

·         Monitor customer and production quality.

·         Initiate appropriate corrective and preventative actions to ensure compliance.

·         Provide effective and responsive QC support to Operations Department, while interfacing with Engineering and Materials Departments to resolve customer and manufacturing issues.

·         Implement and revise quality alerts and work instructions as needed.

·         Support ISO certification, while fully participating in preparation, audits, and follow-throughs.

·         Able to complete PPAPs, APQP, statistical capability studies, and continuous improvement plans.

·         Analyze raw data and transform it into useful and effective action plans.

·         Support the Quality Engineer in day to day duties, planning, and coordination, as needed.

·         Other assignments as required.

REQUIRED POSITION QUALIFICATIONS:

Education

·         Bachelor’s degree in Quality or Engineering; or equivalent expertise in directly related work experience.

Experience

·         Three (3) plus years’ experience in manufacturing in a quality-related role; or a quality-related position in a machining environment.

PREFERRED QUALIFICATIONS

·         ASQ preferred.

·          Solid leadership skills, with a talent for critical thinking and problem solving methods and applications.

·         Excellent organizational and project management skills.

·         Familiar with statistical methods, ISO or TS process; GD&T knowledge preferred.

·         Solid ability to read and interpret drawings and design specifications.

·         Computer literate in Microsoft Suite applications.

·         Solid written, verbal, and interpersonal communication skills.

·         Lab experience in a metallurgical and/or machining environment is a plus.

WORK ENVIRONMENT/PHYSICAL DEMANDS:

·         Able to work in an office environment.

·         Able to work in a machining environment.

·         Able to work in a heat treat facility environment.

·         Able to walk, stand, and climb stairs.

Contact:

Josh Whisnant

National Staffing Manager-PEAK Technical Staffing

Phone: (877)963-7325

Email: joshwhisnant@peaktechnical.com

posted 1/25/2012

TDM & Associates is actively recruiting for a Quality Manager for our east central Illinois client.  This high-visibility position requires self-direction, flexibility, strong organizational and problem-solving skills, and close working relationships with individuals at various levels within the plant and at other Company locations. The QC Manager reports directly to the Corporate Director of Quality, with dotted line reporting to the Plant Manager.

The ideal candidate will have the following background:

·         8+ years of hands-on Quality experience in an FDA-regulated environment, including at least 3 years of management experience. Some of the experience should be in consumer packaged products i.e. OTC drugs, consumable devices, or cosmetics. The candidate should have had overall responsibility for the Quality function at a site, or have worked in multiple Q areas i.e. QC, QA, auditing, etc. with supervisory experience in several areas.

•     Solid familiarity with Quality Control methods and procedures for personal care products.

·         Knowledge of GMP regulations and ISO 9000 or equivalent Quality Systems requirements, and practical compliance methods.

·         Demonstrable experience in problem identification, investigation and resolution.

·         Excellent oral and written communications skills. The candidate must have a customer service orientation and be able to work effectively with diverse constituencies to quickly resolve issues.

·         A Bachelor’s degree in a relevant science or engineering discipline is required.

Specific duties include:

·         Manage the QC Department team (12 FTE’s).

·         Oversee all inspection, testing, document review and release activities to ensure that raw materials, WIP and finished products meet established specifications.

·         Manage the investigation and resolution of discrepancies, nonconformances and other issues affecting quality.

·         Set Quality Department priorities and schedules in close coordination with Operations, such that production goals are met while adhering to quality standards.

·         Administer and maintain various Quality System monitoring programs including department , plant and supplier performance, CAPA, Annual Product Reviews, and Cost of Quality

·         Manage the plant validation/qualification program

·         Audit plant operations to GMP and QMS standards

Interested Candidates should submit their resume to:  Julie Blodgett:   julieb@tdm-assoc.com

Quality Engineer

posted 1/25/2012

Responsibilities:

1.      Support the Quality Management System (QMS) components, including document control to manage work instructions, performing audits and completing audit reports, and following up on corrective actions.

2.      Perform process capability studies to evaluate the design of new products and processes to validate and qualify for production.

3.      Investigate customer inquiries and complaints regarding product quality.

4.      Responsibility for accuracy and effectiveness of automated inspection systems.

5.      Develop standards and methods for inspection, testing, and evaluation.

6.      Devise sampling procedures and design and develop forms and instructions for recording, evaluating, and reporting quality and reliability data.

7.      Utilize statistical analysis and problem solving techniques to reduce the cost of poor quality and resolve quality issues.

8.      Provide management with status reports including: process verification, customer complaints, corrective and preventive action, internal audits, process capability, and product certification / rating status.

9.      Lead, manage and participate in a variety of projects across multi-disciplinary, cross-functional teams.

10.  Document and communicate project status, engineering changes, and other information to managers, engineers, and technicians.

11.  Coordinate training on new production methods and monitor their implementation.

12.  Make decisions based on collection of data; manage risks effectively; be aware of impact of decisions on other departments.

13.  Support identification of root causes of failures and low productivity, and implementation of solutions to prevent reoccurrence.

14.  Work with Engineering and Operations personnel to review, update, and maintain procedures related to development of products/processes.

15.  Support performance of ergonomics evaluations on processes and implement solutions to minimize injuries.

16.  Utilize and understand statistical Design of Experiments and regression analysis to model process response surfaces.

17.  Maintain an effective working relationship with other departments within Tru Vue.

18.  Provide specific support and training for other departments as requested.

19.  Must be able to travel and work off-shifts as needed.

Education and Experience:  (Minimum requirements)

1.      An undergraduate degree in quality, business administration, science, engineering, or related field (or equivalent experience).

2.      Previous quality experience required, manufacturing preferred.

3.      Formal Lean Six Sigma training required (Apogee training provided).

4.      Working knowledge of statistical analysis software (i.e. Minitab, SPCXL, SPSS)

5.      Previous programming experience (Visual Basic, Wonderware, or other programming language)

6.      American Society for Quality CQE certification strongly preferred.
 

Attributes:

1.      Effective verbal and written communication skills.  Proven ability to compile information and produce accurate written documents and reports in a professional format.

2.      Strong knowledge of quality management systems and related industry standards. 

3.      Auditing experience, experience developing and sustaining effective auditing systems.

4.      Demonstrated skill in leading continuous improvement projects.

5.      Demonstrated ability to develop and document processes.

6.      Demonstrated creativity to explore and apply ideas and technologies in innovative ways.

7.      Ability to read, write and understand work instructions (English).

8.      Math and computer skills.

9.      Ability to work and interact effectively with a variety of people at all levels inside and outside the organization.

10.  Personal motivation and ability to work with minimal supervision.

11.  Safely perform essential job responsibilities.

Communication Expectations:

The position routinely requires verbal and written communication in English in order to complete the daily business requirements.  Verbal communications include, but are not limited to: team meetings to discuss daily department requirements, work instructions to direct reports, performance feedback, presentations to management or customers, project meetings with peers and management, safety instructions and training, and performance reviews.  Written communications include, but are not limited to: department paperwork, projects updates, safety walkthroughs, new hire paperwork, performance reviews, purchase orders, continuous improvement projects, and communications with peers, customers, and management.

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  For specific lifting, pushing and pulling thresholds for this position, please see HR.

While performing the duties of this job, the employee is regularly required to stand, walk, and use hands to finger, handle, or feel objects, tools, or controls.  The employee is frequently required to talk or hear and reach with hands and arms.  The employee must regularly lift and/or move up to 30 pounds and occasionally lift and or move up to 50 pounds.  The employee is occasionally required to climb, stoop, kneel, or crouch.  Vision requirement for this job include close vision, depth perception, and the ability to adjust focus.

Work Environment  

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.  Reasonable accommodations may be made to allow individuals with disabilities to perform the essential functions.

The noise level in the Production environment is usually loud.  While performing the duties of this job, the employee regularly works near moving mechanical part.  The employee is occasionally exposed to vibration and risk of electric shock.  Production Environment includes varying temperatures (heat and cold).

posted 1/28/2012

In this role, you would be responsible for providing leadership and management for the quality function and sustain the quality philosophy and lean culture. Establish, maintain, and optimize an effective quality management system.

DUTIES INCLUDE:

• Primary Customer representative for Quality functions.

• Develop and Monitor Quality Personnel including direct and indirect reports.

• Develop, Implement, Monitor, and Report Quality Metrics.

• Manage Company and Customer audits.

• Support and lead the training of all applicable standards

• Coordination of training for quality system documentation (SOP, Quality Plans, Work Instructions).

• Understand, implement, and maintain knowledge of all industry compliance standards, including: ISO9001, ISO 13485, FDA QSR, ITAR, AS9000, NADCAP, Quality Systems, etc.

• Knowledge of medical device standards is required.

• Additional duties as assigned.

IDEAL BACKGROUND WILL INCLUDE:

• A minimum of a Bachelors degree in technical field or equivalent experience is required for this position; Master's degree is preferred.

• 7 years professional experience

• 3 or more years of Medical Device industry experience

• American Society for Quality (ASQ) Certified Quality Manager, Engineer or Auditor a definite plus.

• QSR Certification (Quality System Requirements) as defined by the FDA 820 requirements

• Work experience with FDA Assessors and/or other Regulatory Affairs professionals

• Experience in a Class III/PMA product environment

Gina McDermott

TECHNICAL RECRUITER

STERLING ENGINEERING
Corporate Office                                          

977 North Oak Lawn Avenue                 
Elmhurst, IL  60126                                     
P: 630-993-3433                                             
F: 630-993-3483

gmcdermott@sterling-engineering.com

Website: www.sterling-engineering.com

Are we connected? www.linkedin.com/in/ginamarie29

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