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Category: Quality
Location: H3401 - Plant 9 Manchester NH - Manchester, NH 03103 US (Primary)
Job Description:
Sanmina Corporation (Nasdaq: SANM) is a leading integrated manufacturing solutions provider serving the fastest-growing segments of the global Electronics Manufacturing Services (EMS) market. Recognized as a technology leader, Sanmina Corporation provides end-to-end manufacturing solutions, delivering superior quality and support to Original Equipment Manufacturers (OEMs) primarily in the communications networks, defense and aerospace, industrial and semiconductor systems, medical, multimedia, computing and storage, automotive and clean technology sectors. Sanmina Corporation has facilities strategically located in key regions throughout the world.
Quality Engineer
Job Purpose:
With assistance from senior Quality Management, implement and maintain a Quality Management System compliant with ISO 13485:2016. Assist the department in the implementation of ISO 13485:2016. Conduct internal and supplier audits as required. Develop, apply, revise and maintain quality standards for processing materials into partially finished or finished products. Design and implement methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and/or production equipment. Analyze reports and returned products and recommend corrective action. Prepare documentation for inspection/testing procedures.
Nature of Duties/Responsibilities:
- Provide oversight of the implementation/maintenance of an ISO 13485:2016/QRS 21CFR part 820 compliant system.
- Assist in the maintenance of an AS9100/ISO 9001 compliant quality system.
- Provide day-to-day quality engineering support for specific customer programs.
- Interface closely with operations, manufacturing and test engineering, along with program management, in all aspects of the customer program.
- Responsibility, Authority and Accountability for customer Product and Process Quality including continual quality improvement, risk analysis and reduction, as well as corrective and preventive action responses.
- Customer interface for all regular Quality Engineering level communication.
- Utilize Six Sigma methodologies for process improvements.
- Lead the MRB team to complete all related tasks.
Education and Experience:
- Bachelor’s Degree in Electrical, Electronic, Industrial Engineering or similar and/or a Junior Quality Engineer working on a degree program.
- 5+ years Quality Engineering experience in a manufacturing environment, preferably in the medical device industry.
- Experience and knowledge of ISO 13485:2016 and one or more of the following quality management systems (AS9100, ISO 9001).
- Solid experience with medical core tools i.e. PFMEA, Control Plans, SPC, and MSA. Experience with validation for IQ, OQ and PQ.
- Ability to translate customer quality requirements into executable plans.
- Ability to create a culture and processes that foster change and learning.
- Lean/Six Sigma implementation experience preferred.