Quality Systems Manager - Medical Device/Tooling
Technology
Job Description
Our client is currently seeking a Medical Device Quality Systems - Tooling
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- Bachelor’s degree in Engineering, Quality, or related field.
- Demonstrated years of experience in medical device manufacturing quality systems, with direct ownership of QMS processes.
- Demonstrated experience implementing ISO 13485 and successfully achieving certification.
- Hands-on experience completing FDA Establishment Registration
- Strong working knowledge of 21 CFR Part 820, ISO 13485, and applicable regulatory guidance.
- Proven success leading internal and external audits.
- Excellent communication, documentation, and cross-functional leadership skills.
- Experience in injection molding, assembly, machining, or other precision manufacturing environments.
- ASQ certifications (CQE, CQA, CMQ/OE) or equivalent.
- Familiarity with electronic QMS platforms.
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Full Benefits with Healthcare etc
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