The Judge Group

Medical Device Quality Systems - Tooling

• 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.