QA Product Complaint Specialist

Scorpion Therapeutics; Bridgewater (MA); On-site; USD 81,000 - 103,000; Full time

Job summary

Scorpion Therapeutics seeks a Medical Device Quality Complaint Specialist to support the complaint process in Bridgewater, NJ (onsite 3 days/week). You will handle intake, follow-up, investigations, and trending while ensuring regulatory compliance and timely adverse event reporting.

You will act as a technical SME, collaborate across departments, and contribute to CAPA and process improvements with meticulous documentation and strong stakeholder communication.

Qualifications

• Associate degree or equivalent in engineering or life sciences preferred.
• 3+ years of quality assurance experience in regulated environments.
• Experience with patient/consumer complaint intake and investigations.
• Strong documentation, communication and regulatory knowledge.

Responsibilities

• Receive and triage patient/device complaints with completeness.
• Conduct/root-cause investigations and document resolutions.
• Ensure adverse events are reported within 24 hours.
• Provide complaint training and cross-departmental support.
• Track, trend, and report complaint data and CAPA opportunities.

Skills

Quality Assurance

Regulatory compliance

Communication

Project management

Microsoft Office

Education

Associate degree in Engineering/Life Science

Tools

QMS software

Job description

About the Role

Reporting to the Director, Product Quality Complaints, the Medical Device Quality Complaint Specialist supports the medical device complaint process. Responsibilities include accurate complaint intake, replacement need assessment, troubleshooting with complainants, patient follow-ups, complaint investigations, and tracking/trending of complaint data. Based in Bridgewater, NJ HQ (onsite 3 days/week).

What You’ll Do

• Receive initial patient calls on medical devices; follow up for additional information and coordinate product returns.
• Enter commercial, clinical and/or compassionate use complaints into the internal software system/QMS.
• Review assigned complaints for complete/accurate information, regulatory compliance actions, replacement needs, and unreported adverse events.
• Serve as a technical product subject matter expert and troubleshoot with patients/caregivers.
• Conduct complaint investigations (root cause, resolution) and respond to complainants.
• Ensure adverse events are reported within 24 hours.
• Provide product and complaint training to internal and external stakeholders.
• Partner cross-departmentally to improve Quality Assurance effectiveness.
• Manage workload/call volume within pre-defined KPIs.
• Identify improvement opportunities for complaint/device support processes; share best practices.
• Support complaint trending investigations and associated CAPA.

Who You Are / Qualifications

• Associate degree in Engineering, Life Science, or related discipline (preferred).
• 3+ years of relevant Quality Assurance experience.
• Required: Patient calls/complaints intake experience in a regulated industry.
• Knowledge of cGMPs and Good Documentation Practices.
• Excellent verbal and written communication.
• Ability to manage projects and variable workloads; highly organized with strong attention to detail.
• Proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook).
• Demonstrate collaboration, accountability, passion, respect, and integrity.

Skills/Conditions

• Ability to interact successfully in a dynamic, culturally diverse workplace.

Travel

Minimal travel up to 10%.

Pay Range

$81,000.00–103,000.00 annual.