About This Role

The Quality Specialist-Post Market will support the growth and continuous improvement of the Complaint Handling and Quality System, providing hands-on support to ensure complaints are reviewed and assessed in a timely manner. Duties include but are not limited to, day-to-day complaint review, investigation reports, adverse event reporting, and complaints log and trend maintenance.

Duties in this role include:

• Evaluates complaints to determine reportability in accordance with 21 CFR Part 803 Medical Device Reporting, European Vigilance Reporting, etc.
• Performs and/or coordinates complaint investigations and gathering of additional information, working closely with other departments to complete investigation reports
• Evaluate all information from a technical perspective to ensure appropriate analysis and investigation is complete
• Ensures issues are being addressed and escalated in a timely manner
• Maintains complaints log.
• Participates in process improvements.
• Perform other quality and regulatory-related duties as assigned.

What You Need for this Position:

• Bachelor’s Degree or Associate Degree in science, technology, or medical fields
• 3- 5 years of experience in Quality Assurance and / or a complaint processing role.
• Previous experience in medical devices with working knowledge of ISO 13485, FDA 21 CFR 820, European Union MDD /MDR is an asset
• Strong problem-solving skills, critical-thinker, and experience at investigating and resolving complex issues.
• Understand basic principles of good technical writing skills and be able to articulate findings and formulate conclusions.
• Must work across functional teams within the organization and seek input from Product Quality, Product Development Engineers, and other departments for complaint investigation.
• Identify problems and lead projects to improve processes, procedures and/or practices; recommend and resolve solutions.
• Excellent communication (verbal and written) and interpersonal skills required.
• Demonstrated experience with MS Word, Excel, Adobe Acrobat, and other commonly used software systems.
• Basic knowledge of Quality Systems (CAPA/non-conformances/SCARS) a plus
• Must be able to work under minimum supervision and in a team environment.
• Must be a positive and energetic team player.
• Must be able to work at office for near future, shifting to hybrid once onboarding is complete.
• Experience with software/firmware complaints a plus

What's In It For You

iRhythm GBS Philippines is committed to providing an exciting career path for every team member, with unlimited learning opportunities for you. Our key focus is to ensure a healthy and well-balanced work life, which is why we provide you with comprehensive health and life insurance benefits, with eligible dependent coverage. We offer a competitive compensation package and above industry standard paid leave benefits. 

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