Manager, Manufacturing Quality

Manager, Manufacturing Quality / Quality Manager, Medical Device Manufacturing

Parsippany and Budd Lake, NJ (hybrid) · Hybrid · Full-time

My client needs a hands-on quality leader to own the manufacturing quality system at their medical device site in Northern New Jersey. You'll make Quality part of daily manufacturing decisions instead of inspected in after the fact.

Why you should apply

• Serve as the site's Quality Management Representative and Deputy Management Representative for North America
• A seat on the site leadership team
• Hybrid schedule
• Medical, dental, vision, FSA, 401k, PTO, life and disability insurance, and a comprehensive leave program

What you'll be doing

• Lead, coach, and develop the Quality team
• Own floor presence, disposition decisions, and final product release
• Own the CAPA system and lead nonconformance, deviation, and complaint investigations
• Drive supplier quality and internal audits
• Keep the site ready for customer, certification, and regulatory inspections

About you

• Be able to do the job as described.
• Working knowledge of ISO 13485, FDA 21 CFR 820 (QMSR), and ISO 14971, applied on the manufacturing floor
• Medical device manufacturing background
• Able to travel 10%, domestically and possibly internationally

How to apply

We'd love to see your resume, but we don't need it to have a conversation. Email Santiago St. James at [email protected] and tell me why you're interested. Or, if you do have a resume ready, apply here.