Quality Assurance Specialist
4 weeks ago
Sanmina Corporation, a leading integrated manufacturing solutions provider, seeks a Quality Assurance Specialist to implement and maintain a Quality Management System compliant with ISO 13485:2016. The ideal candidate will assist the department in the implementation of ISO 13485:2016, conduct internal and supplier audits, and develop quality standards for processing materials into partially finished or finished products.
Key Responsibilities:
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.
Requirements:
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.
About Sanmina Corporation:
Sanmina Corporation 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.
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