Job Description
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 ongoing 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:
o Reviewing and approving Risk Management Plans.
o The development, implementation, and approval of Hazard Analyses, FMECAs, and other Risk Analysis documentation.
o 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.
o Coordinate the efforts of individuals and teams performing investigations.
* Assist in the development, review, and approval of Design History File documentation.
o 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
o A degree in a related STEM discipline (Physics, Mathematics, etc.) may be considered with sufficient professional experience.
* Minimum 5-8 years of experience in Quality Engineering in a regulated environment (Medical Device).
* Must have a minimum of 1 year experience supporting new product development.
* Experience with compliance with applicable standards and regulations such as 21 CFR 820, ISO 13485:2016, and ISO 14971:2019 is strongly preferred.
o Experience supporting EU fielded products is a plus.
* Experience developing and leading quality system procedures is required.
* Experience with direct responsibility for Risk Analysis and Design Transfer is preferred.
* Experience supporting regulatory body submissions.
* Experience participating in internal and external audits.
* 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 era.
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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