Sr Quality Engineer

Katalyst Healthcares & Life Sciences

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Job Summary:

The Sr Quality Engineer will support product development and cleanroom build activities within a medical device environment.
The role focuses on ensuring compliance with quality systems, regulatory standards, and supporting design assurance, risk management, and validation activities in collaboration with cross-functional teams.

Roles & Responsibilities:

Perform Quality Engineering activities related to product development and ongoing cleanroom build support
Ensure NPD processes comply with the quality system and applicable regulatory standards
Update risk management and design control files and maintain relevant quality documentation
Develop and execute test method validations and qualification plans
Support design verification and facilitate process validation and commercialization activities related to multi-site transfer
Work collaboratively with cross-functional teams, including R&D, manufacturing, regulatory, clinical, and marketing
Other duties assigned by Leadership

Education & Experience:

Bachelor's degree in Engineering or Scientific field & 4+ years' experience OR Master's degree or equivalent in Engineering or Scientific field & 3+ years' experience
Strong preference for candidates with experience in NPD, Design Assurance (DA), and Quality Engineering
Proficient understanding of medical device operations and/or manufacturing processes; medical device experience strongly preferred
Relevant experience in product development, quality assurance, and/or related fields
Knowledge and understanding of Engineering and Quality principles, theories, and concepts
Understanding of ISO 13485
Experience developing, updating, and maintaining technical content of risk management files
Basic understanding of statistical techniques; experience using statistical software (e.g., Minitab) is a plus
Experience in test method development including validation and/or fixture development
Solid problem-solving, organizational, analytical, and critical thinking skills
Good documentation and communication skills with attention to detail
Ability to build productive working relationships and interact professionally with all organizational levels
Ability to manage competing priorities in a fast-paced environment

Location

Irvine, CA