Medical Device Quality Systems - Tooling

The Judge Group; New Jersey; On-site; USD 90,000 - 150,000; Full time

Job summary

The Judge Group is seeking a Medical Device Quality Systems - Tooling professional in New Jersey to lead QMS ownership and drive regulatory compliance across product lines. Ideal candidates have hands-on experience with ISO 13485 implementation and FDA Establishment Registration, and can liaison with cross-functional teams to ensure quality across manufacturing processes.

Must demonstrate strong auditing capabilities, thorough documentation, and clear communication.

Qualifications

• Bachelor’s degree in Engineering, Quality, or related field.
• Proven experience owning QMS processes in medical device manufacturing.
• Implemented ISO 13485 and achieved certification.
• FDA Establishment Registration experience.
• Strong knowledge of 21 CFR Part 820 and ISO 13485.
• Led internal and external audits.

Skills

QMS ownership

Auditing

Cross-functional leadership

Regulatory knowledge

Education

Bachelor’s degree in Engineering, Quality, or related field

Tools

Electronic QMS platforms

Job description

Our client is currently seeking a 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.

Full Benefits with Healthcare etc#JDP