Sr. Quality Engineer II

Sr. Quality Engineer II - Medical Devices (Ophthalmology)

Join a team that's redefining the future of ophthalmic treatment. We're seeking a Sr. Quality Engineer II to support the manufacturing and continuous improvement of our innovative medical devices. In this role, you'll ensure flawless product transfers into production, lead risk management initiatives, and champion quality across operations, development, and compliance.

What You'll Do:

• Drive quality on the manufacturing floor - from nonconformance investigations to process optimization.
• Lead risk management activities and maintain compliance with ISO 14971.
• Ensure sterility assurance with gamma sterilization oversight, dose audits, and environmental monitoring.
• Support product validation (IQ/OQ/PQ), CAPAs, and quality system improvements.
• Collaborate with R&D, Operations, Clinical, and Regulatory teams to bring new products to market and elevate existing ones.
• Act as a quality leader, guiding audits and embedding a culture of compliance and excellence.

What You Bring:

• 8+ years of relevant experience (5+ years in medical devices required; 10+ preferred).
• Strong knowledge of 21 CFR Part 820, ISO 13485, and ISO 14971.
• Background in sterilization methods (gamma preferred) and lab testing.
• Bachelor's degree in Engineering, Science, or related field.
• ASQ certifications (CQE, CQA, CBA) a plus.
• Detail-oriented, highly organized, and a natural collaborator.

Why Join Us?

This is more than a job - it's a chance to shape life-changing devices that help people see the world more clearly. If you thrive on solving complex quality challenges, influencing cross-functional teams, and raising the bar in medical device manufacturing, we want to meet you.