Product Complaint Analyst II – Medical Devices

HemaSource is looking for a detail-focused and analytical Product Complaint Analyst II to support the intake, evaluation, investigation, and reporting of medical device product complaints. This role directly contributes to patient safety and ensures our products meet global regulatory standards. You will be part of a highly collaborative Quality team that values accuracy, critical thinking, and a commitment to continuous improvement.

If you enjoy problem-solving, working with technical data, and partnering across Quality, Engineering, and Regulatory teams, this is an excellent opportunity to grow your career in a fast-paced and mission-driven environment. You will play a vital role in supporting compliance with FDA regulations, international standards, and internal quality system requirements while helping drive improvements in product performance and customer satisfaction.

Key Responsibilities

• Receive, review, and process medical device product complaints, ensuring accurate documentation and timely assessment.
• Conduct thorough complaint investigations using root-cause analysis and cross-functional input.
• Ensure compliance with FDA, ISO 13485, EU MDR, and internal quality system requirements.
• Prepare and submit required regulatory reports (MDRs, vigilance reports) within strict timelines.
• Analyze complaint data to identify trends and contribute to CAPA and continuous improvement efforts.
• Communicate clearly with internal teams and external customers regarding complaint status and findings.
• Maintain accurate, audit-ready records, complaint metrics, and documentation.
• Manage LMS activities including training assignments, system maintenance, and compliance reporting.

Qualifications

Why Join Us

Physical Requirements

Who We Are :

HemaSource is an innovative logistics solution partner that combines best-in-class analytics and high-quality medical product supply to specialty ambulatory clinics. Our mission is to drive customer operational efficiencies and related cost savings in high volume ambulatory care clinics. HemaSource's patented data analytics software tool and our superior customer service have enabled us to become the preferred disposables provider to the plasma collection market.

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