Senior Quality Engineer

Katalyst Healthcares and Life Sciences

Irvine, CA

Job Summary:

The Senior Quality Engineer will perform Quality Engineering activities supporting product development and ongoing cleanroom build efforts, ensuring New Product Development (NPD) processes comply with quality systems and applicable regulatory standards.
The role works cross-functionally to support design verification, process validation, and commercialization activities.

Roles & Responsibilities:
•

Perform Quality Engineering activities related to product development and ongoing cleanroom build support
Ensure NPD processes comply with 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
Perform other duties as assigned by Leadership

Education & Experience:

Bachelor's degree in Engineering or Scientific field with 4+ years of experience OR Master's degree or equivalent in Engineering or Scientific field with 3+ years of experience
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 13485Experience 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
Strong documentation and communication skills with attention to detail
bility to build productive working relationships across all organizational levels
bility to manage competing priorities in a fast-paced environment

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Vacancy posted 3 days ago

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