Quality Operations Specialist - Medical Devices & Compliance

Merrimack Manufacturing; Manchester (NH); On-site; USD 60,000 - 85,000; Full time

Job summary

Merrimack Manufacturing in Manchester, NH, is seeking a Quality/Manufacturing Associate to support quality operations in a fast-paced medical device environment, including production, inspection, and testing for process validation and commercial builds.

You will assist quality engineers with nonconformances, deviations, CAPA follow-up, DHR reviews, and change orders, coordinating with Production, Engineering, Materials, and QA to ensure regulatory compliance.

Qualifications

• 2+ years of experience in manufacturing or quality control of medical devices.
• Experience with compliance to 21 CFR 820 and ISO 13485:2016 preferred.
• Proficient with Microsoft Office (Word, Outlook, Excel).
• Self-starter with strong organizational and communication skills.
• Ability to manage multiple priorities and drive tasks to closure.

Responsibilities

• Support final inspection and acceptance of medical devices.
• Assist in processing nonconformances, deviations, and rework authorizations.
• Perform Device History Record (DHR) reviews for accuracy and regulatory compliance.
• Identify errors in DHRs and coordinate corrections with production or quality.
• Collaborate with Production, Engineering, Materials, and QA on quality projects.
• Provide admin and technical support for change orders, training records, and CAPA follow-up.
• May perform inspections of components, materials, devices, and documents.
• Interact daily with cross-functional teams and external auditors/customers.

Skills

Quality operations

Analytical thinking

Communication skills

Education

Associate degree or equivalent in Manufacturing/Quality/Mechanical

Tools

Microsoft Office

Job description

Merrimack Manufacturing in Manchester, NH, is seeking a Quality/Manufacturing Associate to support quality operations in a fast-paced medical device environment, including production, inspection, and testing for process validation and commercial builds.

You will assist quality engineers with nonconformances, deviations, CAPA follow-up, DHR reviews, and change orders, coordinating with Production, Engineering, Materials, and QA to ensure regulatory compliance.