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Principal Quality Engineer
- Posted 15 January 2025
- LocationIrvine
- Job type Permanent
- Reference209700
- Contact NameJeremy Burling
Job description
About the Role
We are seeking a highly motivated and experienced Principal Quality Engineer to join our dynamic team. In this critical role, you will be responsible for ensuring the quality and compliance of our innovative Class III medical devices, with a strong focus on active implantable medical devices (AIMDs). You will play a key role in driving continuous improvement within our quality system and supporting the successful launch and lifecycle management of our products.
Key Responsibilities:
We are seeking a highly motivated and experienced Principal Quality Engineer to join our dynamic team. In this critical role, you will be responsible for ensuring the quality and compliance of our innovative Class III medical devices, with a strong focus on active implantable medical devices (AIMDs). You will play a key role in driving continuous improvement within our quality system and supporting the successful launch and lifecycle management of our products.
Key Responsibilities:
- Failure Analysis: Conduct thorough root cause investigations of product failures, including:
- AIMD-specific analysis: Analyze failures related to electronic components, firmware, batteries, and other critical subsystems.
- Utilize various analytical tools and techniques, such as:
- Electrical testing: Perform in-depth electrical characterization and failure mode analysis.
- Root Cause Analysis (RCA) methodologies: 5 Whys, Fishbone diagrams, Fault Tree Analysis.
- Statistical analysis: Data analysis to identify trends and patterns in failure data.
- Generate comprehensive failure reports with clear conclusions and recommended corrective and preventive actions (CAPAs).
- Quality System Management:
- Contribute to the development, implementation, and maintenance of the Quality Management System (QMS).
- Ensure compliance with relevant regulations and standards (e.g., ISO 13485, 21 CFR 820, IEC 60601-1).
- Participate in internal and external audits.
- Support the development and maintenance of quality plans and risk management documentation.
- Product Development Support:
- Provide quality engineering input throughout the product lifecycle, from design and development to post-market surveillance.
- Review design documents, risk management files, and test protocols.
- Participate in Design Control activities and Failure Mode and Effects Analysis (FMEA).
- Collaborate closely with cross-functional teams (e.g., R&D, Manufacturing, Regulatory Affairs).
- Continuous Improvement:
- Identify and implement process improvements to enhance product quality and efficiency.
- Analyze quality data to identify trends and areas for improvement.
- Lead or participate in quality improvement projects.
- Regulatory Support:
- Assist in the preparation of regulatory submissions (e.g., PMA, IDE).
- Respond to regulatory inquiries and audits.
- Bachelor's Degree in Electrical Engineering or a related engineering discipline.
- Minimum 7 years of experience in Quality Engineering within the medical device industry, with a strong emphasis on Class III devices.
- Proven experience in failure analysis of AIMDs.
- Experience with electrical testing and characterization of electronic components and systems.
- Strong understanding of relevant quality standards (e.g., ISO 13485, 21 CFR 820).
- Excellent analytical and problem-solving skills.
- Strong communication and interpersonal skills, with the ability to effectively collaborate with cross-functional teams.
- Proven ability to work independently and as part of a team.
- Experience with statistical analysis tools and techniques (preferred).
- Experience with root cause analysis methodologies (preferred).
- Experience with regulatory submissions (preferred).
