Job Description

Are you enthusiastic about advancing medical technology and enhancing patient outcomes? Join our rapidly growing medical device company that's transforming healthcare with innovative solutions.

Your Impact

As a Senior Quality Assurance Engineer, you will play a critical role in ensuring product excellence and adherence to regulatory standards for pioneering medical technologies. Your expertise will directly shape products that improve patient care and safety.

What You'll Do

• Lead quality initiatives throughout product development and manufacturing processes.
• Conduct FMEA, CAPA, and root cause analysis investigations.
• Collaborate with cross-functional teams to establish and enhance quality management systems.
• Ensure compliance with FDA regulations and ISO standards.
• Create and maintain quality documentation and procedures.
• Mentor junior team members and drive continuous improvement initiatives.

What You Bring

• Bachelor's degree in Engineering, Life Sciences, or a related field.
• 3+ years of quality engineering experience in the medical devices/healthcare sector.
• Thorough understanding of FDA regulations, ISO 13485, and ISO 14971.
• Proven experience with quality tools (FMEA, CAPA, Six Sigma).
• Strong analytical and problem-solving skills.
• Excellent communication and teamwork abilities.

Bonus Points

• CQE certification.
• Experience with Class II or III medical devices.
• History of successfully implementing quality management systems.

Why This Role?

• Be part of a fast-growing company at the forefront of medical innovation.
• Work alongside a dedicated team committed to enhancing healthcare.
• Enjoy competitive compensation and a comprehensive benefits package.
• Pursue career growth in a rapidly expanding organization.

Ready to Make an Impact?

If you're excited about shaping the future of medical technology while upholding the highest quality standards, we want to hear from you. Please send your resume and a brief note about your interest to Will.Macy@lumicity.io with the subject line "Senior Quality Assurance Engineer."

Lumicity proudly represents leading innovators in the medical device industry and is committed to diversity and inclusion in our recruitment process.

Job Tags

Similar Jobs