Product Complaint Lead (San Francisco Bay Area)
Rincon Search Group, San Francisco, CA, United States
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
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