- 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
- Strong project management, prioritization and leadership skills are requiredMust 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.
- 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.
- Bachelor's Degree or equivalent experience in Manufacturing, Mechanical or related engineering/ life sciences related discipline.
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Sr. Quality Engineer - Manchester, United States - Merrimack Manufacturing
Description
Job Description
Job DescriptionMerrimack 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:
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