A Product Quality Engineer evaluates and tests products and manufacturing systems, to ensure that products are produced that meet quality and performance standards as well as safety and regulatory requirements. Develops product quality standards and monitors production and product testing.
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.
Education:
Bachelor's degree or equivalent experience in Industrial, Mechanical or related engineering / life sciences related discipline.
