Quality ManagerApply Now
Location: Sunnyvale, California 94089
Employment Type: Contract
Contract length: 12 Months
Job Summary: Responsible for ensuring Quality Management System (QMS) is compliant with required regulations and applicable standards. Drives activities to maintain compliance and meet new regulatory requirement.
- Champion and advocate for Quality Management System (QMS)
- Manages and maintains the following functions/processes within the QMS: Management Review, Corrective & Preventative Action, Internal Audits, Document Control & Employee Training
- Participates in local Management Quality Review Meetings. Prepares and presents reports assessing the suitability and effectiveness of assigned areas of the quality system
- Provides appropriate training on quality system procedures as required and complies with all quality system procedures
- Bachelor’s degree (BA or BS) in a technical discipline preferred
- 4-6 years related experience in a medical device or pharmaceutical company or equivalent combination of education and experience required
- Excellent working knowledge of medical device Quality System Regulations (21CFR820), ISO 13485, MDD, CMDR, MHLW Ministerial Ordinances and Brazilian requirements
- Knowledge in device regulatory affairs desired. Computer literate: able to use word processing, spreadsheet programs, databases
- Strong knowledge of corrective action, problem solving and root cause analysis processes and tools.
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