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Merrimack Manufacturing is Hiring a Sr. Quality Engineer Near Manchester, NH
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
- 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.
Job Summary
Full Time
$93k-109k (estimate)
06/11/2024
06/24/2024
merrimackmfg.com
Casper, WY
<25
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The following is the career advancement route for Sr. Quality Engineer positions, which can be used as a reference in future career path planning. As a Sr. Quality Engineer, it can be promoted into senior positions as a Quality Assurance Engineer IV that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Sr. Quality Engineer. You can explore the career advancement for a Sr. Quality Engineer below and select your interested title to get hiring information.
