Quality Engineer
Manchester, NH
Full Time
Quality
Mid Level
DEKA 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. The position reports 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:
How you will make an impact:
- 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 recent professional experience with medical devices as QE in a regulated manufacturing environment.
- Must be detail oriented and have strong communication both written and verbal.
- 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
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 & 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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