Quality Assurance Manager
Company Name:
American Empire Manufacturing
Our History
American Empire Manufacturing (AEM) is a leading unit dose contract packaging and filling company providing professionalism and outstanding customer service to businesses serving the life sciences, electronic, cosmetic and a variety of niche markets.
For more than a decade, American Empire Manufacturing (formerly Great Midwest Packaging, LLC) has been providing unique, high quality products and processes for industry through the invention of plastic fusion molding. Our fusion molding capabilities combined with filling, sealing and innovative packaging solutions provides our customers with a high quality unique product presentation. We are a US based manufacturer, with operations located in Waukegan,
illinois
and products distributed globally.
Position Overview
This Quality Assurance Manager position is a 6-month contract assignment with the intent to hire after 6 months. The ideal candidate will provides QA leadership for manufacturing plant by implementing a strategy for improving quality standards, goals and objectives, in an effort to achieve cGMP compliance.
Essential Duties
Closely assess facility, employees, procedures and policies and establish a written plan to bring operation into cGMP compliance.
Achieve ISO 13485 certification.
Determine the value and need for FDA registration.
Review existing SOP's for clarity and accuracy and edit and train personnel as appropriate.
Determine procedural gaps and write, seek approval and train personnel on SOP's as needed.
Support manufacturing by monitoring and investigating the effectiveness of the product line quality plan to identify, categorize, correct, and prevent defects or issues related to productivity, downtime and equipment issues.
Support continuous improvement efforts to improve productivity through lean principles including but not limited to line layout and balancing, WIP reduction, scrap reduction, material flow and equipment downtime.
Train in-process inspectors and provide them with clear inspection instructions and standards of work to drive improvements in the quality of the products. Ensure actual inspector activities are reflected in appropriate documentation.
Develop and implement a calibration and preventative maintenance program.
Develop and maintain a relationship with the customer's quality representative(s).
Focus on product, process, and paperwork quality by incorporating the following activities:
Support and/or lead activities for identification of root causes of non-conformances. If a CAPA is issued support the efforts to ensure the item is closed in an appropriate amount of time.
Support AEM Supplier Quality with supplier audit program and supplier changes.
Train personnel on incoming/in-process SOP's and inspection methods.
Provide support and expertise in DOE, predictive reliability, process/product/equipment validations and analytical problem solving techniques.
Lead all client and FDA audits and support internal audit programs as an auditor.
Work closely with AEM team and customer to smoothly and successfully transfer projects into manufacturing by clearly understanding the receiving and in-process inspection requirements.
Provide leadership and direction on project teams as it relates to process development.
Expectations and Background
Bachelor of Science degree in Engineering preferred
Minimum of 4 years quality manufacturing work experience or equivalent (not entry level)
Experienced in quality systems (ISO13485, QSR and/or 21 CFR 820)
Proficient with reading written specifications, production documentation, using calibrated inspection equipment such as gauges, calipers, smart scope, pull test and other inspection equipment.
Demonstrated experience of leadership role in quality systems.
Leadership ability and organizational skills
Strong team oriented professional with good interpersonal skills who is hands-on with a high energy approach to work
Proficiency in the use of PC and programs, particularly Excel and Word to create procedures, work instructions, forms etc. along with Minitab.
Ability to communicate ideas and information clearly, effectively, and frequently (oral and written).
Execute tasks in a timely manner without direct supervision.
Able to prioritize tasks.
Preferred
Qualifications:
CQE, CQA, ASQ, Lean Six Sigma
Medical Device experience.Estimated Salary: $20 to $28 per hour based on qualifications.
American Empire Manufacturing
Our History
American Empire Manufacturing (AEM) is a leading unit dose contract packaging and filling company providing professionalism and outstanding customer service to businesses serving the life sciences, electronic, cosmetic and a variety of niche markets.
For more than a decade, American Empire Manufacturing (formerly Great Midwest Packaging, LLC) has been providing unique, high quality products and processes for industry through the invention of plastic fusion molding. Our fusion molding capabilities combined with filling, sealing and innovative packaging solutions provides our customers with a high quality unique product presentation. We are a US based manufacturer, with operations located in Waukegan,
illinois
and products distributed globally.
Position Overview
This Quality Assurance Manager position is a 6-month contract assignment with the intent to hire after 6 months. The ideal candidate will provides QA leadership for manufacturing plant by implementing a strategy for improving quality standards, goals and objectives, in an effort to achieve cGMP compliance.
Essential Duties
Closely assess facility, employees, procedures and policies and establish a written plan to bring operation into cGMP compliance.
Achieve ISO 13485 certification.
Determine the value and need for FDA registration.
Review existing SOP's for clarity and accuracy and edit and train personnel as appropriate.
Determine procedural gaps and write, seek approval and train personnel on SOP's as needed.
Support manufacturing by monitoring and investigating the effectiveness of the product line quality plan to identify, categorize, correct, and prevent defects or issues related to productivity, downtime and equipment issues.
Support continuous improvement efforts to improve productivity through lean principles including but not limited to line layout and balancing, WIP reduction, scrap reduction, material flow and equipment downtime.
Train in-process inspectors and provide them with clear inspection instructions and standards of work to drive improvements in the quality of the products. Ensure actual inspector activities are reflected in appropriate documentation.
Develop and implement a calibration and preventative maintenance program.
Develop and maintain a relationship with the customer's quality representative(s).
Focus on product, process, and paperwork quality by incorporating the following activities:
Support and/or lead activities for identification of root causes of non-conformances. If a CAPA is issued support the efforts to ensure the item is closed in an appropriate amount of time.
Support AEM Supplier Quality with supplier audit program and supplier changes.
Train personnel on incoming/in-process SOP's and inspection methods.
Provide support and expertise in DOE, predictive reliability, process/product/equipment validations and analytical problem solving techniques.
Lead all client and FDA audits and support internal audit programs as an auditor.
Work closely with AEM team and customer to smoothly and successfully transfer projects into manufacturing by clearly understanding the receiving and in-process inspection requirements.
Provide leadership and direction on project teams as it relates to process development.
Expectations and Background
Bachelor of Science degree in Engineering preferred
Minimum of 4 years quality manufacturing work experience or equivalent (not entry level)
Experienced in quality systems (ISO13485, QSR and/or 21 CFR 820)
Proficient with reading written specifications, production documentation, using calibrated inspection equipment such as gauges, calipers, smart scope, pull test and other inspection equipment.
Demonstrated experience of leadership role in quality systems.
Leadership ability and organizational skills
Strong team oriented professional with good interpersonal skills who is hands-on with a high energy approach to work
Proficiency in the use of PC and programs, particularly Excel and Word to create procedures, work instructions, forms etc. along with Minitab.
Ability to communicate ideas and information clearly, effectively, and frequently (oral and written).
Execute tasks in a timely manner without direct supervision.
Able to prioritize tasks.
Preferred
Qualifications:
CQE, CQA, ASQ, Lean Six Sigma
Medical Device experience.Estimated Salary: $20 to $28 per hour based on qualifications.
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