Job Description
Hiring: Complaints Coordinator (flexible title)
Are you a seasoned complaint handling professional with a passion for improving patient safety and product quality? Our Fridley-based Class III active implantable medical device company is seeking a Senior Complaint Coordinator with 10+ years of experience to join our growing Quality team.
What You’ll Do:
- Lead and oversee the complaint management process for complex, high-risk active implantable devices.
- Ensure compliance with FDA, ISO 13485, MDR, and global regulatory requirements.
- Act as a subject matter expert (SME) for complaint investigations, root cause analysis, and CAPA activities.
- Collaborate cross-functionally with R&D, Clinical, Regulatory, and Quality to drive timely, high-quality complaint resolution.
- Prepare complaint trend analyses, risk assessments, and reports for senior leadership and regulatory bodies.
- Mentor and provide guidance to junior complaint specialists.
What We’re Looking For:
- 10+ years of complaint handling experience in the medical device industry (Class III or implantable device experience strongly preferred).
- Deep understanding of global complaint handling regulations (21 CFR 820, ISO 13485, EU MDR).
- Strong background in root cause investigation and risk management.
- Exceptional organizational, communication, and leadership skills.