Medical Device Compliance Specialist (Contract)

Position Summary

The Quality Compliance Specialist is responsible for investigating customer complaints, making initial reporting decisions, facilitating investigations, preparing medical device reports, generating customer letters, and ensuring completeness and consistency of complaint documentation.

This is an onsite, contract role.

Duties & Responsibilities

Complaint Investigation & Reporting

• Investigate complaints daily and perform preliminary classification.
• Elevate complaints requiring further review for reporting (e.g., Medical Device Reporting, Medical Device Vigilance, or other international event reporting).
• Ensure all potentially reportable complaints are escalated to appropriate management levels.
• Evaluate documentation for completeness and consistency; assign additional actions as necessary to close complaints.
• Escalate complaints involving new failure modes and collaborate with OEM, Engineering, Field Personnel, and Quality Assurance teams.
• Participate in post-market adverse event investigations for the US, Europe, and other international regulatory bodies.
• Ensure all required medical device reports are submitted per company procedures.

Collaboration & Communication

• Collaborate with clinical staff on hazard evaluations and patient risk/safety investigations.
• Monitor complaint trends and escalate emerging issues to management.
• Provide support during internal and external audits regarding complaint handling processes.
• Provide training to internal teams (e.g., customer-facing teams) on complaint handling procedures.
• Interface with customers and hospital risk management personnel to obtain complaint-related information.
• Draft and review customer and regulatory body responses related to complaints.
• Ensure all customer responses are addressed appropriately and in a timely manner.

Other Responsibilities

• Perform other duties or special projects as assigned.

Minimum Qualifications

• 2–3 years of experience in the medical device industry.
• Prior experience with MedWatch and familiarity with regulatory reporting requirements (e.g., MDRs, Vigilance reports).
• Knowledge of FDA regulations (21 CFR Part 820 & Part 803) and ISO 13485 standards.
• Experience managing medical device complaint files and quality records.

Required Skills

• Strong computer proficiency.
• Effective teamwork and communication (written and verbal).
• Ability to work independently with strong focus and attention to detail.
• Excellent organizational and documentation skills.

Preferred Qualifications

• Clinical experience or background.
• Direct experience in complaint handling and adverse event reporting.

Education

• Required: High School Diploma or GED.
• Preferred: Bachelor’s degree in Engineering, Life Sciences, or equivalent education and experience.
• Highly Desirable: Bachelor’s degree in Sciences or Clinical background.