- Work cooperatively with cross functional design team members and project management to determine the best approach for on-going compliance with applicable SOPs and regulations, such as 21 CFR 820 and ISO 13485
- Participate in and lead Risk Management activities in accordance with ISO 14971
- The development, implementation, and approval of Hazard Analyses, FMEAs, and other Risk Analysis documentation.
- Lead investigations including root cause identification, corrective actions, and verification of effectiveness, through use of data analysis, inductive and deductive reasoning, and problem solving skills.
- Coordinate the efforts of individuals and teams performing investigations.
- Use experience within manufacturing and monitoring of medical devices, to provide guidance in Root Cause Analysis and CAPA.
- Use experience with engineering and technology to identify and ensure compliance with applicable standards and regulations.
- Ensure the accurate documentation / recording of information to be used in communication with partners and regulatory bodies.
- Prepare detailed work plans and procedures such as Validation Plans.
- Evaluate and approve proposed design or manufacturing process change.
- Drive system and process improvements.
- Provide reliability and statistical analysis.
- Participate in internal and external audits.
- Bachelor's degree in an engineering or related STEM discipline. Additional training and experience may be considered in lieu of degree.
- Minimum 2-5 yrs. of experience as QE in a regulated manufacturing environment.
- Experience with compliance, with applicable standards and regulations such as 21 CFR 820, ISO 13485, and ISO 14971 is preferred.
- Ability to:
- Multitask and carry tasks through to completion
- Manage multiple sources of data and develop reports
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Quality Engineer - Manchester, United States - DEKA Research & Development
Description
Job Description
Job DescriptionDEKA R&D has an immediate opening for a Quality Engineer to work in the Quality Department in a dynamic Medical Device Research and Development environment and will report to the Quality Manager. We are seeking a Quality Engineer to provide Quality guidance in a dynamic, fast-paced medical device research, development, and manufacturing and distribution environment.How you will make an impact:
About DEKA:
One hour from the beach, Boston, and the mountains, the historic Amoskeag Millyard once housed the largest textile mills in the world. It is now home to DEKA Research and Development, where we are taking the same innovation and cutting-edge technology into the modern age.
Behind DEKA's brick walls sits a team of professionals who strive to make a difference every day through thoughtful engineering, design, and manufacturing. Here at DEKA, some of the most innovative and life-changing products of our time are created, and new ideas are always welcome and explored.
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