What are the responsibilities and job description for the Senior Quality Engineer position at DEKA Research & Development?
DEKA Research & Development, located in Manchester, NH, is seeking a Senior Quality Engineer to provide design quality leadership in a dynamic, fast-paced medical device R&D and manufacturing environment.
How you will make an impact:
- Work cooperatively with other team members and in compliance with applicable standards and regulations such as 21 CFR 820 and ISO 13485:2016
- Use critical thinking to determine the best approach
- Use experience within product development or production and processing of medical devices to provide guidance and assistance in the development of new products
- Participate and lead in Risk Management activities in accordance with ISO 14971:2019 such as:
- Development, implementation, and approval of FMEAs
- Risk analysis of new product designs
- Use experience with engineering and technology to identify and ensure compliance with applicable standards and regulations
- Assist in 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
- Coordinate the efforts of individuals and teams performing investigations
- Ensure the accurate documentation and recording of information to be used in communication with partners and regulatory bodies
- Prepare detailed work plans such as Master Validation Plans
- Lead system and process improvements using six sigma tools
- Provide reliability and statistical analysis
- Conduct test method validations for formal testing
- Participate in internal and external audits
- Interface with partners on quality topics
How you will be successful in this role:
- Bachelor’s degree in industrial, mechanical or related engineering discipline required
- Minimum 5 years' experience in any suitable occupation related to quality control of medical devices
- Experience with medical devices and direct responsibility for Risk Analysis and Design Transfer required
- Experience with compliance, applicable standards and regulations such as 21 CFR 820 and ISO 13485:2016 required
- Experience developing and leading quality system procedures required
- Experience supporting regulatory body submissions preferred
- Experience participating in internal and external audits preferred
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.
