Job Details

Product Complaint Lead

?? East Bay Area, CA (Hybrid)

Rincon Search Group is partnering with a rapidly growing Bay Area medical device company to identify a Product Complaint Lead to own it's complaint handling program. The company is advancing a novel platform for chronic neurological conditions and is entering a strong phase of growth.

This is a high-impact role where this individual will serve as the subject matter expert for product complaints, leading investigations, driving root cause analysis, and ensuring compliance across FDA and ISO standards. The position offers a balanced mix of strategic influence and hands-on execution, with strong visibility to executive leadership.

As the organization scales, this role will play a key part in building and shaping the complaint function, with the opportunity to hire and mentor a direct report.

Key Responsibilities

• Own the complaint handling process end to end, from intake through closure
• Lead cross functional investigations with Quality, Engineering, Operations, and Clinical teams
• Drive root cause analysis using established quality tools (FMEA, fishbone, etc.)
• Analyze complaint data and identify trends to support product and process improvements
• Lead recurring complaint review meetings and present findings to leadership
• Ensure compliance with FDA, ISO 13485, and EU MDR requirements
• Support audit readiness and participate in regulatory inspections
• Partner on CAPA and continuous improvement initiatives

Qualifications

• Bachelor's degree in Engineering or related field preferred
• Experience in a regulated medical device or pharmaceutical environment
• Hands-on experience with complaint handling and/or post-market quality
• Strong investigative and problem-solving skills
• Familiarity with FDA regulations and ISO 13485
• Excellent communication and documentation skills

Compensation & Benefits

• Competitive base salary
• Bonus potential
• Comprehensive benefits package
• Hybrid work schedule