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Posted: Wednesday, January 31, 2018 7:34 PM

Sr. Supplier Quality Engineer (QA0023)
Ascensia Diabetes Care16 reviews-Parsippany, NJ
Job Summary
Ascensia Diabetes Care is a global specialist diabetes care company, dedicated to helping people living with diabetes. Our mission is to empower people living with diabetes through innovative solutions that simplify and improve their lives. We use our innovation and specialist expertise in diabetes to develop high quality solutions and tools that make a positive, daily difference for people with diabetes.
LOCATION:Parsippany, NJ
POSITION PURPOSE:Ascensia Diabetes Care has an opportunity within our Supplier Quality organization to provide guidance on the quality requirements for products and processes, from the initial transfer of products/processes to production, through maintenance and improvements over the product lifecycle. You will evaluate and maintain suppliers, including auditing for compliance and oversight of preventive and corrective actions. You will provide oversight of quality operations at 3rd party manufacturers, contract packagers and service providers as an extension of Ascensia operations. You will have the opportunity to lead Quality improvement teams.
MAJOR TASKS AND RESPONSIBILITIES OF POSITION:
+ Serve as a direct Quality interface to contract manufacturers/packagers supporting quality and productivity goals, proactively monitoring and measuring product/process quality and performance trends, and troubleshooting of production/release issues.
+ Develop and oversee equipment qualification and process validation plans and lead continuous improvement projects based on process/product trends, customer complaints, industry standards and government regulations.
+ Assure quality systems of OEMs, contract manufacturers and suppliers are maintained and acceptance criteria are in alignment with component/product use and customer expectations. Develop and maintain Quality Agreements with suppliers.
+ Work with suppliers to troubleshoot escalated complaints, ensure robust root cause analysis and effective corrective and preventive actions.
+ Represent Quality on Product Lifecycle Management (PLM) teams, New Product Development Quality Element Teams and other project teams.
+ Provide Quality oversight of product/process change requests from suppliers, and from Ascensia, ensuring appropriate regulatory review and adequate validation to support requested changes. Review and approve Engineering Change Orders, ensuring appropriate specifications and Bills Of Materials are in place.
+ Serve as internal and supplier quality auditor, managing planning, execution, reporting and closure of audits and audit findings.
+ Establish feedback mechanisms with Procurement, Supply Chain, Regulatory and Commercial internal customers to ensure alignment in management of suppliers.
QUALIFICATIONS:
+ Graduate Degree in one of the life sciences or an engineering discipline, or equivalent in experience and training.
+ Ten (10) years of experience in Quality Assurance or a related field. At least five (5) years of experience in the management of a scientific discipline.
+ Medical device or pharmaceutical experience strongly preferred.
+ Excellent analytical skills and judgment.
+ Good understanding of statistical techniques.
+ Broad understanding of Good Laboratory and Good Manufacturing Practices, appropriate Diabetes Care policies, and various government regulations.
+ Strong organization, communication, leadership, and management skills to direct diverse, multi-disciplinary functions, prepare and manage budgets, and select, train, and motivate a qualified staff.
+ Ability to interface with people from different cultures, with varying levels of proficiency in a common language.
+ Ability to travel up to 40%.
YOUR APPLICATION:Ascensia offers a wide variety of competitive compensation and benefits programs. If you meet the requirements of this unique opportunity, and are driven by innovation and the desire to improve the lives of our patients, we encourage you to apply now. Job postings will remain open for a minimum of five business days and are subject to immediate closure thereafter without additional notice.
TO ALL RECRUITMENT AGENCIES:Ascensia does not accept unsolicited third party resumes.
Ascensia is an Equal Opportunity Employer.
IND123
Job Type: Full-time
Associated topics: business, cost efficient, industrial engineer, manufacturing engineer, methods engineer, project, sap, supply, supply chain

Source: http://www.jobs2careers.com/click.php?id=4798755478.96


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