Manager, Manufacturing Quality

Jacobs Management Group•Parsippany, NJ
•Hybrid

About The Position

This is a hands-on quality leadership role responsible for the manufacturing quality system at a medical device site in Northern New Jersey. The goal is to integrate Quality into daily manufacturing decisions rather than treating it as an after-the-fact inspection. The role includes serving as the site's Quality Management Representative and Deputy Management Representative for North America, with a seat on the site leadership team.

Requirements

  • 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

Responsibilities

  • 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

Benefits

  • Medical, dental, vision, FSA, 401k, PTO, life and disability insurance, and a comprehensive leave program
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