Post Market Complaint Specialist

iRhythm Technologies, Inc.; Iloilo City; On-site; PHP 650,000 - 900,000; Full time

Job summary

iRhythm Technologies, Inc. in Iloilo is seeking a Quality Assurance professional to evaluate complaints and coordinate investigations in accordance with 21 CFR Part 803, ISO 13485, and related standards.

You will work across functions to ensure timely resolution and maintain the complaints log. The ideal candidate has a Bachelor’s or Associate degree in science or a related field, 3–5 years in QA or complaint processing, and strong writing and communication skills to articulate findings and

Qualifications

• Bachelor’s or Associate Degree in science, technology, or medical fields.
• 3–5 years of experience in Quality Assurance and/or complaint processing.
• Experience in medical devices with knowledge of ISO 13485, FDA 21 CFR 820, EU MDR is a plus.
• Strong problem-solving and written/oral communication skills.
• Ability to work across functional teams for investigations.

Responsibilities

• Evaluates complaints to determine reportability per 21 CFR Part 803 and related rules.
• Coordinates complaint investigations and gathers additional information with other departments.
• Reviews information from a technical perspective to ensure complete analysis.
• Ensures issues are addressed and escalated in a timely manner.
• Maintains the complaints log and participates in process improvements.
• Performs other quality and regulatory duties as assigned.

Skills

Quality Assurance

Complaint Processing

Regulatory Knowledge

Cross-functional Collaboration

Technical Writing

Education

Bachelor’s or Associate Degree in Science/Technology/Medical Fields

Tools

MS Word

Excel

Adobe Acrobat

Job description

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:

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

Location:

Iloilo

As a part of our core values, we ensure an inclusive workforce. We welcome and celebrate people of all backgrounds, experiences, skills, and perspectives. iRhythm Technologies, Inc. is an Equal Opportunity Employer. We will consider for employment all qualified applicants with arrest and conviction records in accordance with all applicable laws.

iRhythm provides reasonable accommodations for qualified individuals with disabilities in job application procedures, including those who may have any difficulty using our online system. If you need such an accommodation, you may contact us at [e-mail]

About iRhythm Technologies

iRhythm is a leading digital healthcare company that creates trusted solutions that detect, predict, and prevent disease. Combining wearable biosensors and cloud-based data analytics with powerful proprietary algorithms, iRhythm distills data from millions of heartbeats into clinically actionable information. Through a relentless focus on patient care, iRhythm’s vision is to deliver better data, better insights, and better health for all.

Make iRhythm your path forward. Zio, the heart monitor that changed the game.