Medical Device Complaint Specialist

Job Description

Job Description

Job Title : Medical Device Complaint Specialist

Job Summary :

The Medical Device Complaint Specialist is a key member of our quality compliance team, responsible for expertly investigating customer complaints, making initial reporting decisions, and coordinating comprehensive investigations. This role ensures accurate and complete documentation of complaints, prepares necessary medical device reports, and communicates effectively with stakeholders. The Specialist plays a vital part in maintaining regulatory compliance, safeguarding patient safety, and supporting continuous product improvement.

Key Responsibilities :

• Investigate customer complaints daily by performing initial classifications and determining which cases require escalation for regulatory reporting, such as Medical Device Reports (MDRs) or Vigilance reports for international authorities.
• Ensure all potentially reportable complaints are promptly escalated to appropriate management and regulatory bodies, maintaining compliance with applicable regulations.
• Review complaint documentation for accuracy, completeness, and consistency; initiate further actions or investigations as needed.
• Collaborate with OEM, engineering, field personnel, and quality assurance teams to investigate new failure modes and product issues.
• Participate in post-market surveillance activities, including adverse event reviews and regulatory reporting for the US, Europe, and other international agencies.
• Prepare, review, and submit medical device reports in accordance with company procedures and regulatory requirements.
• Work closely with clinical staff on hazard evaluations and assessments of patient safety risks associated with complaints.
• Monitor complaint trends, escalating significant issues to management for timely resolution.
• Support internal and external audits by representing the complaint handling process.
• Provide training to internal teams on complaint management procedures and regulatory compliance requirements.
• Interface with customers and hospital risk management personnel to gather information related to complaints.
• Draft and review customer communications and responses to regulatory agencies, ensuring timeliness and accuracy.
• Address complaints requiring customer response or follow-up as part of quality and regulatory processes.
• Assist with special projects or duties related to quality compliance as assigned.

Qualifications & Experience :

Minimum Qualifications :

Preferred Qualifications :

Education :

Why Join Us?

If you are detail-oriented, communicative, and passionate about quality and safety in medical devices, we invite you to apply and become a vital part of our team.

Company Description

Marquee Staffing has built a reputation on expert local market knowledge, unparalleled personalized service and the ability to deliver winning candidates and job opportunities.

Marquee operates offices located conveniently throughout Southern California. Each branch is full-service, providing temporary, contract, contract-to-hire and direct placement services for a diverse set of clients. Each branch has recruiters who specialize in key industries, ensuring that our clients get the best match possible for each open position and that our candidates get expert guidance in their career path.

Apply with us today!

Company Description

Marquee Staffing has built a reputation on expert local market knowledge, unparalleled personalized service and the ability to deliver winning candidates and job opportunities.\r\n\r\nMarquee operates offices located conveniently throughout Southern California. Each branch is full-service, providing temporary, contract, contract-to-hire and direct placement services for a diverse set of clients. Each branch has recruiters who specialize in key industries, ensuring that our clients get the best match possible for each open position and that our candidates get expert guidance in their career path.\r\n\r\nApply with us today!