Quality Engineer
Company: DEKA Research & Development
Location: Manchester
Posted on: February 13, 2026
|
|
|
Job Description:
Job Description Job Description 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: 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.
How you will be successful in this role: 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.
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 QxAj8LwaBj
Keywords: DEKA Research & Development, Manchester , Quality Engineer, Engineering , Manchester, New Hampshire
