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 year of experience in Quality Engineering in a regulated environment (Medical Device preferred)

• 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 is strongly preferred. 

• 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.

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