Quality Engineer I - Instrumentation Quality Engineer

Join Our Team as a Quality Engineer in Lake Forest, CA!

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 Role

In 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

Preferences

• 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!

Subject Line: Quality Engineer Opportunity in Lake Forest, CA

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