Merrimack Manufacturing
Merrimack Manufacturing is hiring a full-time Quality Systems Specialist – CAPA in the United States to help safeguard product quality and regulatory compliance across our medical device operations. If you thrive on driving corrective action and continuous improvement, this on-site role is your next career move.
About the Role
As a Quality Systems Specialist – CAPA at Merrimack Manufacturing, you will help sustain and strengthen our Quality Management System (QMS) so that it consistently meets ISO 13485 standards and the broader regulatory expectations that govern medical device manufacturing. Your day-to-day work centers on shepherding Nonconformance (NC) and Corrective and Preventive Action (CAPA) processes from identification through resolution, keeping records accurate and timelines on track.
Key Responsibilities
- Coordinate, monitor, and report on Nonconformance (NC) and CAPA activities throughout their lifecycle.
- Track open quality records and follow up to ensure timely closure and proper documentation.
- Evaluate the effectiveness of corrective and preventive actions after implementation.
- Support and help maintain the Quality Management System in line with ISO 13485 requirements.
- Partner with cross-functional teams to uphold compliance across medical device operations.
Qualifications
- Working knowledge of Quality Management Systems within a regulated manufacturing environment.
- Familiarity with ISO 13485 and applicable medical device regulatory requirements.
- Experience with Nonconformance and CAPA processes, including tracking and effectiveness review.
- Strong organizational, documentation, and follow-through skills.
- Ability to work on-site in the US in a full-time capacity.
About Merrimack Manufacturing
Merrimack Manufacturing operates in the medical device sector, where quality and regulatory compliance are central to everything we build. Our teams are committed to maintaining robust quality systems that protect both our products and the people who depend on them.
How to Apply
Ready to advance quality excellence as a Quality Systems Specialist – CAPA with Merrimack Manufacturing in the US? View the full listing and submit your application to get started.
To apply for this job please visit www.adzuna.com.
Working in US
The United States of America (USA), also known as the United States (U.S.) or America, is a country primarily located in North America. It is a federal republic consisting of 50 states and a federal capital district, Washington, D.C. The 48 contiguous states border Canada to the north and Mexico to the south, with the semi-exclave of Alaska in the northwest and the archipelago of Hawaii in the Pacific Ocean. The United States also asserts sovereignty over five major island territories and various uninhabited islands in Oceania and the Caribbean. It is a megadiverse country, with the world's th
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