ABOUT TSK GROUP

The TSK Group operates globally in medical technologies. Our focus is on innovation that supports both practitioner performance and patient experience—through constant iteration, smart engineering, and attention to detail. With operations across multiple global sites, we work as a close-knit, fast-moving team that values clarity, responsiveness, and accountability in everything we do.

JOB SUMMARY

The Post-Market Surveillance & Complaints Specialist is responsible for managing all aspects of complaint handling and post-market surveillance for medical devices. This includes intake, investigation, regulatory reporting, trend analysis, and cross-functional collaboration to ensure product safety, compliance, and continuous improvement. The role ensures adherence to global regulatory requirements such as FDA 21 CFR 820 and ISO 13485.

QUALIFICATIONS/EDUCATION:

Bachelor’s degree in Engineering, Life Sciences, or a related technical discipline.

EXPERIENCE:

· 3–5 years of experience in quality assurance, complaint handling, or post-market surveillance in a regulated medical device environment.
· Experience in FDA-regulated and/or ISO 13485-certified settings.
· Prior experience with field safety corrective actions and regulatory submissions preferred.

SKILLS & COMPETENCIES:

· Strong technical writing and documentation skills.
· Proven ability to conduct root cause analysis and lead CAPA activities.
· Working knowledge of 21 CFR 820, ISO 13485, and international reporting requirements.
· Proficiency in data analysis and trending tools.
· Experience with electro-mechanical systems, calibration, and process validation is a plus.
· Excellent interpersonal, communication, and problem-solving skills.

· Complaint Handling
· Manage the full lifecycle of product complaints from intake to closure.
· Ensure all complaints are properly documented, investigated, and resolved in a timely manner.
· Communicate effectively with customers during the complaint resolution process.
· Root Cause Analysis & CAPA
· Conduct or coordinate investigations using tools such as 5 Whys or Fishbone diagrams.
· Lead or support the implementation of Corrective and Preventive Actions (CAPAs).
· Serve as CAPA coordinator and guide teams through investigation and documentation.
· Regulatory Reporting
· Assess complaints for regulatory reportability (FDA MDR, EU MIR, Health Canada).
· Prepare and submit required reports to global regulatory bodies.
· Post-Market Surveillance
· Develop and maintain PMS plans and reports in accordance with ISO 13485 and EU MDR.
· Perform trend analysis and data mining to identify product risks or quality signals.
· Monitor field performance data and escalate issues when necessary.
· Documentation & Compliance
· Ensure all activities comply with regulatory standards and internal procedures.
· Support audits and inspections by acting as Subject Matter Expert (SME) for complaints and PMS.
· Cross-functional Collaboration
· Work with Quality, Engineering, Regulatory, Manufacturing, and Customer Support teams.
· Participate in supplier issue resolution and quality improvement initiatives.