Quality Operations Specialist

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

COMPANY OVERVIEW:

Merrimack Manufacturing is amedical device manufacturer located in the Manchester Millyard. We are a growing manufacturing company thatwill play a crucial part in bringing innovative and life changing products to life.

POSITION OVERVIEW:

This position will support manufacturing quality operations in a dynamic, fast-paced, medical device manufacturing environment. This environment includes the manufacture, inspection, and testing of devices for process validation and commercial production.

RESPONSIBILITIES:

• Working under the direction of Quality Engineers support, drive, and coordinate final inspection and acceptance of medical devices.
• Support quality engineers in processing nonconformances, deviations, and rework authorizations by gathering data, updating logs, or drafting documentation.
• Perform Device History Record (DHR) reviews for completeness, accuracy, and compliance to internal and regulatory requirements.
• Identify and document errors or missing information in DHRs and coordinate with production or quality teams for timely correction.
• Work cooperatively with team members on commercial production lines to support quality requirements and projects.
• Provide administrative and technical support for change orders, training records, and CAPA follow-up as assigned.
• May perform inspections for components, materials, devices and documents.
• Position requires daily contact with members of Production, Engineering, Materials, and Quality departments and occasional contact with auditors and customers

QUALIFICATIONS AND SKILLS:

• 2 + years of experience in occupation related to Manufacturing or Quality Control of medical devices.
• Experience with compliance, with applicable standards and regulations such as 21 CFR 820 and ISO 13485:2016 is preferred.
• Experience with Microsoft Office software (Word, Outlook, Excel) required.
• Self-starter and independent individual with strong organizational, time management and communication skills.
• Ability to drive assigned tasks to closure
• Must be able to manage multiple priorities.
• Use critical thinking and deductive reasoning to make risk based decisions.

EDUCATION:

Associate degree or equivalent experience in Manufacturing, Quality, Mechanical or related engineering / life sciences related discipline.