Complaints Supervisor

Responsibilities include but are not limited to:

• Supervise a team of complaint handling specialists and ensure timely and accurate processing of complaints.
• Review and assess incoming complaints to determine regulatory reporting requirements (e.g., MDR, vigilance).
• Ensure complaint investigations are thoroughly documented, and completed within required timelines.
• Collaborate with cross-functional teams (e.g., Quality, Regulatory, Engineering, Customer Service) to resolve complaints and identify root causes.
• Monitor complaint trends and escalate critical issues to management.
• Maintain and improve complaint handling procedures in alignment with QMS and regulatory standards.
• Prepare and present complaint metrics and reports to leadership.
• Support audits and inspections by providing complaint records and process documentation.
• Train and mentor team members on complaint handling procedures and regulatory requirements.

Qualifications required:

• Bachelor’s degree in Engineering, Life Sciences, or related field
• English fluency:  Advance
• 3–5 years of experience in complaint handling or post-market surveillance in the medical device industry.
• 3 years of supervisory or team leadership experience
• Strong knowledge of FDA 21 CFR Part 820, ISO 13485, and EU MDR.
• Experience with complaint management systems (e.g., TrackWise).
• Excellent analytical, communication, and organizational skills.
• Ability to manage multiple priorities in a fast-paced environment.
• Experience Post-Market Surveillance
• Strong time-management skills and an ability to organize and coordinate multiple concurrent projects

Preferred qualifications:

• Six Sigma or ASQ or ISO certifications.
• Experience with CAPA and risk management processes.
• Familiarity with global regulatory reporting requirements.
• Excell /power point high level  knowledge

Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply.

Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law.