Description
Quality Engineer
Location: Manchester, NH
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).
QUALIFICATIONS AND SKILLS:
- 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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