Quality Engineer
Irvine, CA
Schedule:
Standard Office Hours (Full-Time, Onsite, 5 days/week)
Duration:
18-Month Contract
Pay:$54-59/ph
Job Summary:
This role supports the early-stage development and commercialization of innovative cardiovascular therapies. The Quality Engineer will provide leadership and expertise in design assurance throughout the product development lifecycle, ensuring compliance with internal policies and external standards. The position requires close collaboration with cross-functional teams including R&D and Operations, and offers the opportunity to work in a dynamic, fast-paced environment.
Job Responsibilities:
In this role, you will manage and support a variety of projects within the Quality Engineering department. Key responsibilities include:
- Collaborate cross-functionally to support design engineering, design controls, risk management, verification and validation, and quality compliance throughout the product development lifecycle.
- Lead risk management activities, including authoring and maintaining documentation (e.g., risk worksheets, FMEAs) in accordance with ISO 14971.
- Partner with R&D to define strategy, refine product designs, and support design verification/validation including test method development and validation.
- Ensure readiness for product transfer and successful commercialization by supporting manufacturing and quality systems.
- Drive resolution of product and process issues using engineering and quality tools such as Six Sigma, DMAIC, CAPA, and non-conformance investigations.
- Provide mentorship to junior engineers and contribute to a culture of quality within new product development.
- Collaborate with stakeholders to ensure quality and regulatory compliance is embedded throughout the development process.
Essential Skills and Qualifications:
Required Technical Skills:
- Strong knowledge of design control within medical devices.
- Experience with NPD Quality Assurance.
- Risk Management expertise per ISO 14971.
Preferred Skills:
- Design for Six Sigma.
- Experience with Early Human Use programs.
- Familiarity with ISO 13485 and design for manufacturing (DFM).
- CQE/Six Sigma Black Belt certification.
- Background with electronic/data transmission devices is a plus.
Software Proficiency:
- Microsoft Office
- Minitab
Education & Experience:
- Bachelor’s degree in Engineering with at least 4 years of relevant industry experience, or
- Master’s degree in Engineering with at least 3 years of experience.
- Experience in the medical device industry is required.
- Strong documentation, problem-solving, and communication skills are essential.
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