Location: Irvine, CA

Schedule: Standard Office Hours

Duration: 6-Month Contract

Pay range: $44.00 - $49.00




This role supports the development and clinical manufacturing of delivery systems for transcatheter heart valves within a global supply chain environment. The Quality Engineer will collaborate cross-functionally to ensure compliance, drive quality initiatives, and support the transition of new products from pilot to full-scale production.




Key Responsibilities:

• Partner with new product development teams to build quality system test samples and human-use products according to timelines.
• Investigate and resolve moderate manufacturing quality and compliance issues, such as non-conformances and CAPAs.
• Optimize manufacturing processes for efficiency, risk reduction, and improved inspection methods.
• Develop production documentation and training materials to support knowledge transfer.
• Conduct risk assessments on early-stage manufacturing processes (e.g., PFMEAs).
• Support validation of inspection methods for in-process quality checks.
• Lead material review boards to evaluate potentially non-conforming products.
• Monitor product yields and defect rates, using data to drive process improvements.

Qualifications:

• Bachelor's degree in engineering with at least 2 years of medical device industry experience, or a master's degree with 1 year of experience.
• Experience in medical device manufacturing or operations preferred.
• Familiarity with computerized Manufacturing Execution Systems (MES) is a plus.

Skills and Competencies:

• Strong attention to detail and understanding of engineering principles.
• Effective communication and collaboration skills.
• Problem-solving and critical thinking abilities.
• Basic knowledge of statistical tools (Minitab experience preferred).
• Ability to manage multiple priorities in a fast-paced, team-oriented environment.

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