Project Quality Engineer

We are seeking a 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 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 the 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.

• 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.