Quality Systems Manager - Medical Device/Tooling
Judge Direct Placement
Job Description
Our client is currently seeking a Medical Device Quality Systems - Tooling
\n- \n
- Bachelor’s degree in Engineering, Quality, or related field. \n
- Demonstrated years of experience in medical device manufacturing quality systems, with direct ownership of QMS processes. \n
- Demonstrated experience implementing ISO 13485 and successfully achieving certification. \n
- Hands-on experience completing FDA Establishment Registration \n
- Strong working knowledge of 21 CFR Part 820, ISO 13485, and applicable regulatory guidance. \n
- Proven success leading internal and external audits. \n
- Excellent communication, documentation, and cross-functional leadership skills. \n
- Experience in injection molding, assembly, machining, or other precision manufacturing environments. \n
- ASQ certifications (CQE, CQA, CMQ/OE) or equivalent. \n
- Familiarity with electronic QMS platforms. \n
Full Benefits with Healthcare etc
\n#JDP
Vacancy posted 7 days ago
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