Medical Device Quality Systems Engineer (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

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.