Quality Engineer- Project Lead
Quality Engineer- Project Lead
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1 Vacancy
Job Description
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;
- 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.
- Bachelors degree in an engineering discipline
- A degree in a related STEM discipline (Physics mathematics etc. may be considered with sufficient professional experience.
- Minimum 58 year of experience in Quality Engineering in a regulated environment (Medical Devicepreferred)
- Must havea minimum of 1yearexperience supportingnew 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.
- 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 cuttingedge technology into the modern age.
Behind DEKAs 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 lifechanging products of our time are created and new ideas are always welcome and explored.
Required Experience:
Senior IC
Employment Type
Full-Time
