Complaints ManagerJCW Group • Fridley, MN, United States
Complaints Manager
JCW Group • Fridley, MN, United States
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job_description.job_card.job_description10+ 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.
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 :
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Manager • Fridley, MN, United States