Quality Operations Specialist

COMPANY OVERVIEW:Merrimack Manufacturing is a medical device manufacturer located in the Manchester Millyard. We are a growing manufacturing company that will 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.

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