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.

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