Job Description
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.
We are searching for a Senior Quality Engineer to support manufacturing quality operations in a dynamic, fast-paced, medical device manufacturing environment. This environment includes the manufacture, inspection, and testing of devices for design verification, design validation, and commercial production.
Duties & Responsibilities:
* Work under the direction of the Quality Manager to ensure all products, processes, and components meet specifications.
* Participate as a member of cross-functional teams to support new product development, commercial production, material-related design changes, manufacturing and process changes, risk management activities, and compliance projects.
* Ensure compliance with applicable standards and regulations such as 21 CFR 820 and ISO 13485:2016.
* Lead the Device History Records (DHR) review and approval process.
* Lead investigations of nonconformance reports (NCR) and CAPA activities.
* Develop and implement PFMEAs and control plans.
* Lead process and equipment validation activities (IQ, OQ, PQ/PV, TMV).
* Drive manufacturing and quality system improvements.
* Manage customer feedback processes and investigations.
* Author Engineering Change Orders (ECOs) and support their implementation.
* Apply engineering expertise to ensure compliance with standards and regulations.
Education:
Bachelor’s degree or equivalent experience in Manufacturing, Mechanical, or related engineering/life sciences discipline.
Experience:
* Minimum of 5 years of experience related to manufacturing of medical devices within a QMS environment, in a Quality Control or Engineering role.
* Experience with compliance to standards such as 21 CFR 820 and ISO 13485:2016.
* Proficiency with Microsoft Office (Word, Outlook, Excel).
* Experience participating in internal and external audits.
Knowledge & Skills:
* Strong project management, prioritization, and leadership skills.
* Ability to manage multiple priorities effectively.
* Experience with statistical data analysis tools like Minitab.
* Excellent presentation skills for meetings with peers and senior management.
* Critical thinking and deductive reasoning for risk-based decision making.
* Deep understanding of CAPAs, root cause analysis, and the 8D method.
* Excellent oral communication and technical writing skills.
* High attention to detail and accuracy.
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