Merrimack Manufacturing

Merrimack Manufacturing is seeking a Quality Manager to lead their Quality Team, ensuring customer safety and driving continuous improvement. This role involves developing and implementing a 21 CFR 820 QMS, serving as the primary interface with customers, and collaborating with Supply Chain and Operations teams. The ideal candidate will have experience in medical device regulation, FDA inspections, and ERP/PLM systems.

Requirements

• Improve and maintain a quality assurance system
• Develop, implement, manage, and continuously improve a 21 CFR 820 QMS
• Attain and maintain ISO 13485:2016 certification
• Serve as Merrimack Manufacturing’s Management Representative and interface with auditors
• Provide daily guidance to supplier quality engineers and incoming inspection personnel
• Oversee MRB and NCR activities and provide feedback
• Work with the supply chain team to monitor supplier performance
• Work with Operations and Engineering to implement metrics
• Working with the FDA to help drive overall supplier performance and quality