Quality Operations Specialist

Pay Rate Low: 35.00 | Pay Rate High: 40.00

Exciting Quality Operations 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

Quality Operations Specialist I – 2 Positions | Alcon

Location: Irvine, CA | Onsite 5 days/week

Contract: 12-Month Contract | Potential Extension or Conversion

Benefits: Medical, Dental, Holiday, PTO 401K matching

Support medical device complaint investigations, manufacturing quality, troubleshooting, and product/process improvements.

• Investigate and document customer complaints and manufacturing nonconformities
• Troubleshoot returned medical devices
• Support manufacturing quality activities and SAP
• Analyze complaint and manufacturing trends and support corrective actions
• Collaborate with Quality, Manufacturing, R&D, and Supply Chain teams
• Ensure compliance with FDA and ISO 13485 requirements
  
  

Requirements

• 2–5 years of relevant experience
• Medical device troubleshooting experience preferred
• Knowledge of FDA regulations, 21 CFR 820/803 & ISO 13485
• Strong Excel and communication skills
• BS in Electrical or Mechanical Engineering highly preferred; other Engineering/Natural Science degrees considered with relevant medical device experience
  
  

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