Senior Quality Engineer
Merrimack ManufacturingManchester, NH
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Overview
Schedule
Full-time
Education
Engineering (PE)
Career level
Senior-level
Remote
On-site
Job Description
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 positon will 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.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.
- Position requires daily contact with members of Production, Engineering, Materials, and Quality departments.
- Routine contact with design authority and customers; occasional contact with auditors
- 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
- 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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FAQs About Senior Quality Engineer Jobs at Merrimack Manufacturing
What is the work location for this position at Merrimack Manufacturing?
This job at Merrimack Manufacturing is located in Manchester, NH, according to the details provided by the employer. Some roles may also include multiple work locations depending on the requirement.
What pay range can candidates expect for this role at Merrimack Manufacturing?
Employer has not shared pay details for this role.
What employment applies to this position at Merrimack Manufacturing?
Merrimack Manufacturing lists this role as a Full-time position.
What experience level is required for this role at Merrimack Manufacturing?
Merrimack Manufacturing is looking for a candidate with "Senior-level" experience level.
What education level is required for this job?
The education requirement for this position is Engineering (PE). Candidates with relevant qualifications or equivalent experience may also be considered.
What is the process to apply for this position at Merrimack Manufacturing?
You can apply for this role at Merrimack Manufacturing either through Sonara's automated application system, which helps you submit applications 10X faster with minimal effort, or by applying manually using the direct link on the job page.