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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