Quality Engineering S

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.
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.
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.
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; 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.
~ Bachelor’s degree or equivalent experience in Industrial, Mechanical or related engineering / life sciences related discipline.