Lead Project Quality Engineer
4 weeks ago
At DEKA Research & Development, we are seeking a Quality Engineering Lead to provide Quality Leadership on a dynamic, fast-paced medical device research and development team.
Key Responsibilities:
- 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, including reviewing and approving Risk Management Plans, developing, implementing, and approving Hazard Analyses, FMECAs, and other Risk Analysis documentation, and supporting 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.
Requirements:
- 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 years 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.
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