Quality Engineer – San Jose, CA

This position provides basic quality engineering support to all manufacturing processes and assembly operations.  Coordinate and resolve issues with conflicting requirements.  Work with multifunctional teams to ensure that customer specifications and requirements are consistently met.  Supports the documentation efforts to establish quality requirements for manufacturing of component and subassemblies.  Communicates effectively with internal and external customers.



· Work with customers for validation activities including, but not limited to IQ, OQ, PQ, capability (Cpk) studies & Control Plans. Establish related documentation such as protocol, final reports.

· Administration and execution of the document control process in IQMS manufacturing system

· Support injection molding and other quality management processes by providing technical information and feedback from inspection and customers.

· Work with QA Manager to develop & execute plans and product requirements, to ensure provisions for quality are addressed and resolved prior to product shipment.

· Resolve any quality, test, and certification requirements in cooperation with customer and supplier to assure customer drawings/ specifications are met.

· Participate in complaint investigations, failure analysis of returned products, and issues in production. Document findings, provide CAPA, SCAR reports and analysis.

· Responsible for proper documentation for outgoing quality control.

· Participate in MRB (Material Review Board) to review and disposition nonconformities and to work with manufacturing and customer to coordinate corrective actions.

· Other assigned duties as required necessary to meet the business and customer needs of MOS.



· 2-4 years’ quality control experience in a manufacturing environment.

· BS degree in Engineering, Quality Assurance or Science Related field.

· Excellent oral and written communication skills.

· Attention to details and analytical thinking.

· Must be able to read drawings and GD&T and interpret requirements into product quality plan

· Must display a good attitude, willingness to learn, and the ability to get along with others



· Working knowledge perform metrology with CMM programming and inspection instruments (Calipers, micrometers, height gage, etc.)

· Experience with root cause analysis, CAPA implementation and risk management.

· Demonstrated knowledge in ISO: 13485 standards.

Department: Quality Assurance
Job Location: San Jose CA
Shift: First

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