Job Description

Are you passionate about advancing medical technology and improving patient outcomes? Join a rapidly growing medical device company that's revolutionizing healthcare through innovative solutions.

Your Impact

As a Senior Quality Engineer, you'll be at the forefront of ensuring product excellence and regulatory compliance for groundbreaking medical technologies. Your expertise will directly contribute to products that enhance patient care and safety.

What You'll Do

• Drive quality initiatives across product development and manufacturing processes
• Lead FMEA, CAPA, and root cause analysis investigations
• Collaborate with cross-functional teams to implement quality management systems
• Ensure compliance with FDA regulations and ISO standards
• Develop and maintain quality documentation and procedures
• Mentor junior team members and contribute to continuous improvement initiatives

What You Bring

• Bachelor's degree in Engineering, Life Sciences, or related field
• 3+ years of quality engineering experience in medical devices/healthcare
• Deep understanding of FDA regulations, ISO 13485, and ISO 14971
• Hands-on experience with quality tools (FMEA, CAPA, Six Sigma)
• Strong analytical mindset and problem-solving capabilities
• Excellence in communication and team collaboration

Bonus Points

• CQE certification
• Experience with Class II or III medical devices
• Track record of implementing quality management systems

Why This Role?

• Join a fast-growing company at the cutting edge of medical innovation
• Work with a collaborative team dedicated to improving healthcare
• Competitive compensation and comprehensive benefits package
• Career growth opportunities in a rapidly expanding organization

Ready to Make an Impact?

If you're excited about shaping the future of medical technology while ensuring the highest quality standards, we want to hear from you. Send your resume and a brief note about why you're interested to [email protected] with the subject line "Senior Quality Engineer - San Jose."

Lumicity is proud to represent leading innovators in the medical device industry. We are committed to diversity and inclusion in our recruitment process.

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