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 position 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:
- Work cooperatively with other team members and in compliance with applicable standards and regulations such as 21 CFR 820 and ISO 13485:2016 to transition products from development to manufacturing.
- Use experience within medical devices, to provide guidance and assistance in the development of new production processes
- Drive the development, implementation, and approval of PFMEAs and control plans.
- Develop inspection processes and sampling plans according to the risk level of the components, material and devices
- Use experience with engineering and technology to ensure compliance with applicable standards and regulations.
- Ensure all product, processes, and components are within specifications and work with internal team and with customers to resolve any nonconformance issues
- Facilitate the development, implementation, and approval of Device Master Records and Device History Records.
- Review existing procedures and for continuous improvement and improved workflow
- Lead investigations resulting in root cause and corrective actions through use of data analysis, inductive and deductive reasoning, and problem solving skills.
- Use critical thinking and deductive reasoning to make risk based decisions.
- Develop and approve technical documents to plan work, such as Master Validation Plans, Quality Plans, and Qualification Protocols; support execution of work product.
- Collect and evaluate data, lead system and process improvements using six sigma tools
- Provide reliability and statistical analysis of data for investigations, qualifications, test method validations and other Quality related activities.
- Participate in ISO 13485 audits and assist in FDA and other regulatory inspections Will use Microsoft Office software (Word, Outlook, Excel).
- 3 + years of experience in occupation related to Quality Control of medical devices.
- Experience with compliance, with applicable standards and regulations such as 21 CFR 820 and ISO 13485:2016 is required.
- Experience participating in internal and external audits.
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FAQs About 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.