Quality Engineer
Company: DEKA Research & Development
Location: Manchester
Posted on: April 4, 2026
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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.
Keywords: DEKA Research & Development, Nashua , Quality Engineer, Engineering , Manchester, New Hampshire
