Quality Systems Manager - Medical Device/Tooling

Judge Direct Placement; New Jersey; Sur place; USD 90 000 - 120 000; Plein temps

Résumé du poste

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.

Qualifications

• 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.

Connaissances

Cross-functional leadership

Communication

Documentation

Quality systems

Formation

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

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

Outils

Electronic QMS platforms

Description du poste

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.
• 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.