What are the responsibilities and job description for the Quality Assurance Engineering Manager position at Management Recruiters International, Inc.?
Siter-Neubauer & Associates is currently conducting a search for Quality Assurance Engineering Manager :
My Client is a manufacturer of Capital Equipment that is in the Orthopedic Operating Room.
Job Description
They are seeking qualified candidates for their Quality Engineering Manager position located in the South Peninsula area of Northern California. This management position requires quality assurance experience in a medical device environment including validation, inspection, design assurance, documentation control, CAPA, and non-conformance.
Qualifications
- The successful candidate must have a Bachelor's Degree in the Sciences.
- At least 8 years of Quality Assurance experience with a Medical Device Manufacturer and at least 4 years in a managerial role.
- Working knowledge of the listed regulations / standards is required : FDA's 21 CFR Part 820 (Quality System Regulation), CFR Part 806 Medical Device Reporting, and 21 CFR Part 11 (Electronic Records; Electronic Signatures), ISO 13485.
- Have experience in a machine shop environment.
- Mechanically inclined - Understanding of software & electrical circuits.
- There is no RELO and you must be in commuting distance of the Fremont / Hayward / Pleasanton area.
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