Senior Quality Engineer
DEKA Research & DevelopmentManchester, New Hampshire, United States
Posted December 17, 2025
Full Time
About the Company
DEKA Research and Development is a company that strives to make a difference every day through thoughtful engineering, design, and manufacturing.
Job Description
DEKA R&D has an immediate opening for a Sr. Quality Engineer to work in the Quality Department in a dynamic Medical Device Research and Development environment. The position reports to the Director of Quality. We are seeking a Sr. Quality Engineer to provide Quality guidance in a dynamic, fast-paced medical device research, design assurance, manufacturing, and distribution environment.
Requirements
- Bachelor’s degree in an engineering or related STEM discipline.
- Minimum 5 years' experience in any suitable occupation related to quality assurance 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.
- Hands-on experience in Supplier Qualification, Supplier Audits, and Supplier Corrective Action.
Benefits
- Generous Paid Time Off
- 401k Matching
- Retirement Plan