Project Quality Assurance Specialist

2 weeks ago


Manchester, New Hampshire, United States DEKA Research & Development Full time
Job Description

At DEKA Research & Development, we are seeking a highly skilled Project Quality Engineer to join our dynamic team. As a key member of our quality leadership team, you will be responsible for providing quality leadership on a fast-paced medical device research and development team.

Key Responsibilities:
  • Collaborate with cross-functional design team leads and project management to ensure compliance with applicable standards and regulations, such as 21 CFR 820 and ISO 13485:2016.
  • Provide guidance and assistance in the development of new products, leveraging experience in product development or production of medical devices.
  • Identify and ensure compliance with applicable standards and regulations, utilizing experience with engineering and technology.
  • Participate in and lead Risk Management activities in accordance with ISO 14971:2019, including reviewing and approving Risk Management Plans, developing and implementing Hazard Analyses, FMECAs, and other Risk Analysis documentation.
  • Lead investigations, including root cause identification, corrective actions, and verification of effectiveness, utilizing data analysis, inductive and deductive reasoning, and problem-solving skills.
  • Assist in the development, review, and approval of Design History File documentation, ensuring accurate documentation/recording of information for communication with partners and regulatory bodies.
  • Prepare detailed work plans and procedures, such as Anomaly Management Plans, and evaluate and approve proposed design changes.
  • Drive quality as a culture through system and process improvements, providing reliability and statistical analysis.
  • Participate in internal and external audits and interface with partners on quality topics.
Requirements:
  • Bachelor's degree in an engineering discipline, with a degree in a related STEM discipline (Physics, mathematics, etc.) considered with sufficient professional experience.
  • Minimum 5-8 years of experience in Medical Device Quality Engineering, with experience in new product development strongly preferred.
  • Experience with compliance, applicable standards and regulations, such as 21 CFR 820, ISO 13485:2016, and ISO 14971:2019 required.
  • Experience developing and leading quality system procedures required, with direct responsibility for Risk Analysis and Design Transfer preferred.
  • Experience supporting regulatory body submissions and participating in internal and external audits preferred.
  • Strong attention to detail in both verbal and written communication required.

About DEKA Research & Development:

DEKA Research & Development is a leading innovator in the field of medical device research and development, with a team of professionals who strive to make a difference every day through thoughtful engineering, design, and manufacturing. We are committed to creating life-changing products that improve the lives of our customers and patients.



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