Medical Device Quality Systems Lead – Tooling

Judge Direct Placement; New Jersey; Presencial; USD 90 000 - 120 000; Tempo integral

Resumo da oferta

Judge Direct Placement is seeking a Medical Device Quality Systems - Tooling professional in New Jersey with a Bachelor’s degree in Engineering or Quality and demonstrated QMS ownership in medical device manufacturing.

The role requires strong knowledge of ISO 13485, 21 CFR Part 820, and successful audit leadership, plus experience with tooling and precision manufacturing environments. ASQ certification preferred.

Qualificações

• Bachelor's degree in Engineering, Quality, or related field.
• Experience in medical device manufacturing quality systems with ownership of QMS processes.
• Experience implementing ISO 13485 and achieving certification.
• Strong working knowledge of 21 CFR Part 820, ISO 13485, and 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.

Conhecimentos

Cross-functional leadership

Communication

Documentation

Quality systems

Formação académica

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

ASQ certifications (CQE, CQA, CMQ/OE) or equivalent

Ferramentas

Electronic QMS platforms

Descrição da oferta de emprego

Judge Direct Placement is seeking a Medical Device Quality Systems - Tooling professional in New Jersey with a Bachelor’s degree in Engineering or Quality and demonstrated QMS ownership in medical device manufacturing.

The role requires strong knowledge of ISO 13485, 21 CFR Part 820, and successful audit leadership, plus experience with tooling and precision manufacturing environments. ASQ certification preferred.