Exciting Quality Specialist development opportunity to work for a global leader dedicated to helping people see brilliantly. The largest device company in the world – with complementary businesses in Surgical and Vision Care.

PREFERRED:

• Knowledge of FDA regulations (21 CFR 820/803), ISO 13485
• Experience with medical device complaint handling and regulatory reporting (MDR, Vigilance, etc.)
  This job description is a complete list of all desired skills but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you!INDBH:#LI-DNP:

ABOUT THE ROLE:

Join our team as a Quality Operations Specialist and play a key role in ensuring the safety and performance of our innovative medical devices. You’ll lead hands-on investigations, analyze product performance, and support cross-functional improvements — all while helping us stay compliant with global regulatory standards.

KEY RESPONSIBILITIES:

• Investigate and document customer complaints and product issues
• Perform hands-on troubleshooting of returned devices and nonconformities
• Analyze trends in complaints, service calls, and manufacturing issues
• Support complaint intake and coding verification
• Collaborate with cross-functional teams to drive product and process improvements
• Maintain compliance with FDA, ISO 13485, and global quality standards
• Assist with manufacturing line support and quality documentation (e.g., SAP)