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San Jose, California - USD Full Time Posted: Monday, 19 June 2017
 
 
Codman, a member of Johnson & Johnson's Family ofCompanies, is recruiting for a Supplier Quality Engineer, located in San Jose,CA

The Codman Supplier Quality Engineer II position providesoverall quality assurance leadership in the management of External and DirectManufacturing sites engaged in the production of Johnson and Johnson products.The SQE II will provide day to day support for Codman Supplier Qualityobjectives, and overall responsibilities will include, but are not limited to:

. Implement SQ strategy and follow Supplier Qualitystandards

. Manage supplier related Non-Conformities (NC and SCAR's)and Corrective and Preventive Actions (internal CAPA's), and address andcorrect product and process complaints.

. Oversee supplier change requests (SCR) with Procurement

. Support Process Validations and PVE's (First ArticleInspection, Control Plans, Critical to Quality, Capability studies) atsuppliers

. Support Procurement in execution of supplier transferprojects

. Support for Quality Agreement and Change Agreements

. Prepare regular report and supplier quality metrics

. Provide support for quality system design and audit, complianceassessment, and for support of steady state manufacturing processes.

. Ensure comprehensive measurement systems to monitoreffectiveness of quality and reliability systems to identify, bracket, correctand prevent defects.

. Ensure that FDA CFR Part 820 and ISO 13485regulations/standards are understood and followed at suppliers

. The Supplier Quality Engineer II position requiresdemonstrated ability to manage day to day Quality activities, to make effectiveoral and written presentations, to prioritize and analyze problems and applypractical solutions.

. A minimum of a Bachelor's degree is required, preferablyin an Engineering, Life Science, or related discipline.

. A minimum of 2-4 years of experience in a highly regulatedindustry is preferred.

. Experience in the Medical Device industry is preferred.

. FDA CFR Part 820 and ISO 13485 knowledge preferred.

. Auditing background is an asset.

. Strong communication, teamwork, and problem solvingskills.

. Strong in root cause analysis skills.

. Experience or knowledge with machining manufacturingprocesses and injection molding an asset.

. Six Sigma, Lean, or ASQ Certification and trainings anasset.

. This position will require up to 20% travel.

Posted by StartWire



San Jose, California, United States of America
Engineering
USD
Johnson & Johnson
Johnson & Johnson
JS2124_BF0825E31DE77D8D97C46E3F8C278B48_228_I/228112123
6/19/2017 7:50:36 AM

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