Sr. Quality Engineer for Contract Manufacturing

Drive quality activities related to contract manufacturing (CM) services, including supplier qualification, supplier performance, site audits, corrective actions, final inspection and yield improvements.

 

Duties/Responsibilities:Drive quality activities at the contract manufacturer facility (may include but not limited to: supplier qualification, audits, corrective action, improvement, inspection and test and defined yield metrics). Implement and maintain Supplier Quality Management System and processes in align with ISO 13485 QMS requirements. Assist in developing inspection methodology and sampling plans that are in line with the CM quality rating and process capability.Drive/verify RoHs Compliance at the CM in compliance with EU-2002/95/EC Standard for the Restriction of Hazardous Substances. Manage/coordinate and train the 3rd Party quality outsource activities. Review/approve all source inspection reports and audit results submitted.Provide/publish ongoing analysis and trending of defined key metrics. Analyze defect conditions and defect materials as necessary to drive corrective action and continuous improvement efforts at the CM. Provide complete, accurate and effective documented quality plans to ensure quality of product throughout product life. Approximately 20% International travel.

Minimum Qualification Required:

 

· Bachelor of Science Degree in Engineering or related technical discipline.

· Certified Six Sigma Black Belt

· 5-10 years direct experience in Quality engineering/supplier management.

· Proven experience using PPAP methodology and tools.

· General knowledge of documentation control systems including BOM’s, revision control, ECO’s and product traceability.

· Demonstrated working knowledge of process validation,  SPC, DOE, FMEA, and TQM problem solving methods/quality systems

· Familiarity and general understanding with requirements of ISO9001:2000.

· Effective verbal and written communication, analytical, influencing and interpersonal. Must be capable to communicate at all levels.

· Proven experience and skills using Excel, Word, Outlook, Project Management and Power Point software.



 

Additional Desired Qualification/Experience:

 

· Masters Degree preferred.

· ASQ, CQA, CQE is desirable.

· Knowledge of Lean Manufacturing Techniques.

· Prior experience in Package Assembly in an Engineering Capacity.

· Prior experience in Semiconductor Wafer Fab.

· Knowledge of IPC-A-610.