Post Market, Complaint Specialist

IRhythm Technologies Inc.; Manila; On-site; PHP 3,774,000 - 5,031,000; Full time

Job summary

iRhythm is seeking a Quality Assurance professional to evaluate complaints for regulatory reporting and to coordinate investigations in a cross-functional environment. You will ensure accurate analytical conclusions and support continuous process improvements.

The role requires a science/tech background, 3–5 years in QA or complaint handling, and familiarity with ISO 13485 and FDA/EU standards. Office-based with potential hybrid onboarding was mentioned.

Qualifications

• Bachelor’s Degree or Associate Degree in science, technology, or medical fields
• 3-5 years of experience in Quality Assurance or complaint processing
• Knowledge of ISO 13485, FDA 21 CFR 820, EU MDD/MDR is a plus
• Strong problem-solving and analytical skills
• Excellent written and verbal communication

Responsibilities

• Evaluates complaints to determine reportability per 21 CFR Part 803 and related regulations
• Performs and coordinates complaint investigations with cross-functional teams
• Analyze information from a technical perspective and document conclusions
• Maintain complaints log and participate in process improvements
• Work across teams and support CAPA/non-conformances as needed

Job description

**Career-defining. Life-changing.**At iRhythm, you’ll have the opportunity to grow your skills and your career while impacting the lives of people around the world. iRhythm is shaping a future where everyone, everywhere can access the best possible cardiac health solutions. Every day, we collaborate, create, and constantly reimagine what’s possible. We think big and move fast, driven by our commitment to put patients first and improve lives. We need builders like you. Curious and innovative problem solvers looking for the chance to meaningfully shape the future of cardiac health, our company, and your career**About This Role:**What You’ll Be Doing: • 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