Quality Engineer I Instrumentation Quality Engineer
Are you ready to bring your quality engineering expertise to a dynamic team in the heart of Lake Forest, CA? We are seeking a dedicated professional to provide hands-on quality engineering support across the product development lifecycle. Work closely with R&D, Regulatory, and Operations teams to ensure the highest standards in our instrumentation products.
About the RoleIn this role, you will play a critical part in new product development projects and design changes, ensuring quality requirements are met throughout all stages, from development to product transfer. You'll partner with cross-functional teams to provide quality guidance, conduct risk assessments, and drive corrective actions. Your contribution will be pivotal in maintaining compliance with GxP requirements and supporting documentation practices.
Requirements- Bachelor's degree in engineering, life sciences, or a related field
- 2 years of quality engineering experience in the medical device industry, particularly with instrumentation or electromechanical product development
- Experience with design controls, change control, and product impact assessments
- Knowledge of medical device quality systems and regulatory requirements, including ISO 13485 and GxP principles
- Experience with risk management in accordance with ISO 14971
- Ability to work effectively across global, cross-functional teams
- Statistical knowledge for sample size determination and study design
- Familiarity with product and safety standards such as IEC 60601 and ISO 14971
- ASQ Certified Quality Engineer (CQE) certification
- Six Sigma Green Belt or higher
- Strong communication and independent problem-solving skills
Ready to make an impact? Apply now and be part of a team that values innovation and quality excellence. Send your application today!
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