Medical Device Quality Systems - Tooling (1154859)
The Judge Group · Morris, NJ · 3 wk ago
Healthcare$140k/yrFull-time
Location: Morris, NJ
About the role
Our client is currently seeking a Medical Device Quality Systems - Tooling professional.
Pay
$140,000.00 USD Annually - $160,000.00 USD Annually
Benefits
Full Benefits with Healthcare etc
Requirements
- 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
Skills
- 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