Sr. Quality Engineer

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 test of devices for design verification, design validation, and commercial production.

Duties & Responsibilities:

Working under the direction of the Quality Manager, ensure all product, processes, and components are within specifications.

This position may also serve as a member on collaborative cross-functional teams, to support new product development efforts, commercial production, material-related design changes, and manufacturing and process changes, risk management activities, and other compliance projects.

Work in 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 nonconformance reports (NCR) and CAPA investigations.

Lead the development and implementation of PFMEAs and control plans.

Lead process and equipment validation activities (IQ, OQ, PQ/PV, TMV).

Lead manufacturing and quality system improvements.

Lead customer feedback process and investigations.

Author Engineering Change Orders (CO); support CO implementation tasks

Use experience with engineering and technology to ensure compliance with applicable standards and regulations.

Education: Bachelor’s degree or equivalent experience in Manufacturing, Mechanical or related engineering / life sciences related discipline.

Experience:

5+ years of experience related to the manufacturing of medical devices in a QMS environment while being in a Quality Control or Engineering role.

Experience with compliance, with applicable standards and regulations such as 21 CFR 820 and ISO 13485:2016 is required.

Experience with Microsoft Office software (Word, Outlook, Excel) required.

Experience participating in internal and external audits.Knowledge & Skills

Strong project management, prioritization and leadership skills are required

Must be able to manage multiple priorities.

Performing statistical data analysis using Minitab or equivalent.

Presenting and leading meetings with an audience of peers and senior management level.

Use critical thinking and deductive reasoning to make risk based decisions.

Knowledge and comprehensive understanding of CAPAs, root cause analysis, and the 8D method.

Excellent oral communication and technical writing skills.

High level of attention to detail and accuracy.

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Full-time