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Design Quality Engineer
Job in
Irvine, Orange County, California, 92602, USA
Listed on 2026-01-07
Listing for:
Katalyst Healthcares & Life Sciences
Full Time
position Listed on 2026-01-07
Job specializations:
-
Engineering
Quality Engineering
Job Description & How to Apply Below
- Develop quality assurance documentation for new product development and regulatory submissions.
- Maintain and improve quality system processes by identifying and correcting deficiencies.
- Engage in design, development, manufacturing, and risk management activities for new projects.
- Participate in design reviews, identify product risks, and ensure effective mitigation strategies.
- Define and validate design verification and validation test requirements.
- Complete final design verification and validation reports with statistical and graphical support.
- Promote efficient testing practices and support manufacturing process development.
- Utilize statistical analysis and problem-solving techniques to establish product acceptance limits.
- Review and approve inspection plans, routers, and product drawings for new products.
- Support product design transfers to manufacturing facilities.
- Lead risk management activities, including developing risk management plans and conducting reviews.
- Requirements:
- Experience with medical device product development lifecycle, including risk management and design/process verification and validation.
- Applied knowledge of advanced quality tools (FMEA, GD&T, Root Cause Analysis, Mistake Proofing).
- Ability to read and interpret CAD drawings.
- Experience interacting with regulatory agencies (FDA, MoH, TUV).
- Thorough knowledge of US and international medical device regulations.
- Strong understanding of quality concepts (CAPA, audits, statistics).
- Excellent project management, communication, and problem-solving skills.
- Proficiency with analysis programs like Mini Tab.
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