Senior Quality Engineer
Company: DEKA Research & Development
Location: Manchester
Posted on: March 17, 2023
Job Description:
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 topicsHow 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.Powered by JazzHR
Keywords: DEKA Research & Development, Manchester , Senior Quality Engineer, Engineering , Manchester, New Hampshire
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