DEKA Research and Development is seeking a Lead Project Quality Engineer to provide Quality Leadership on a dynamic, fast paced medical device research and development team.
How you will make an impact as a Lead Project Quality Engineer:
- Work cooperatively with cross functional design team leads and project management to determine the best approach for on-going compliance with applicable SOPs and regulations, such as 21 CFR 820 and ISO 13485:2016
- Use experience within product development or production of medical devices, to provide guidance and assistance in the development of new products.
- Use experience with engineering and technology to identify and ensure compliance with applicable standards and regulations.
- Participate in and lead Risk Management activities in accordance with ISO 14971:2019, such as;
- Reviewing and approving Risk Management Plans
- The development, implementation, and approval of Hazard Analyses, FMECAs, and other Risk Analysis documentation.
- Support risk analysis during product anomaly reviews.
- 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.
- Assist in the development, review, and approval of Design History File documentation.
- 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 Anomaly Management Plans.
- Evaluate and approve proposed design changes.
- Drive quality as a culture through system and process improvements.
- Provide reliability and statistical analysis.
- Participate in internal and external audits.
- Interface with partners on quality topics.
How you will be successful in this role as a Lead Project Quality Engineer:
- Bachelor’s degree in an engineering discipline
- A degree in a related STEM discipline (Physics, mathematics, etc.) may be considered with sufficient professional experience.
- Minimum 5-8 yrs. of experience in Medical Device Quality Engineering
- Experience in new product development strongly preferred.
- Experience with compliance, with applicable standards and regulations such as 21 CFR 820, ISO 13485:2016, and ISO 14971:2019 required.
- Experience supporting EU fielded product is a plus.
- Experience developing and leading quality system procedures required.
- Experience with direct responsibility for Risk Analysis and Design Transfer is preferred.
- Experience supporting regulatory body submissions preferred.
- Experience participating in internal and external audits preferred.
- Must have strong attention to detail in both verbal and written communication.
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 & 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.
Top Skills
What We Do
DEKA is one of the leading research and development companies in the country and is the birthplace of some of the most innovative and life-changing products of our time. For over thirty years, DEKA Research & Development Corp. has made Manchester, New Hampshire home. Located about an hour from Boston, the beach, and the mountains, we are situated in the beautiful and historic Amoskeag Millyard buildings located in downtown Manchester.
DEKA continues to be a place where no idea seems too big and where creativity and crazy cool gizmos reign supreme. The engineers, technicians, machinists, designers and all of the other folks who make up DEKA are some of the most creative and innovative professionals you could ever hope to meet. It's a place where one crazy idea can end up being the next greatest invention. At DEKA we embrace the spirit of innovation and constantly aim to turn the impossible into a reality.
DEKA is filled with people who are driven to be among the best and brightest in their field of work. It’s a concentrated bunch of really smart thinkers, doers and problems solvers, who are driven to using innovative design solutions and state-of-the-art technology to improve lives. We all see endless possibilities in the power of technology to do good. Employees have the opportunity to work on diverse projects that have a positive, enduring impact on millions of people worldwide. We are growing! We're always seeking passionate individuals to join our growing team of evolved thinkers.
