Complaints Analyst
Job Summary
Job Description
AliveCor is seeking a Complaints Analyst to join their Quality team in Bangalore. The role involves managing domestic and international product surveillance activities for medical devices, investigating returned products, and collaborating with various departments like Quality, Regulatory, Engineering, and Customer Service. The analyst will assess and evaluate complaints, identify reportable events, and escalate as needed. This position requires ensuring compliance with ISO 13485 and FDA regulations, contributing to post-market surveillance, and supporting risk management activities. The goal is to ensure AliveCor products meet customer expectations and perform as intended.
Must have:
- BS in Science or Engineering.
- 1-3 years experience in regulated industry (Medical Device preferred).
- Document technical information and communicate effectively.
- Experience with FDA 21CFR Parts 820, ISO13485.
- Ability to work under pressure.
- Organized, driven, and results-oriented.
- Good judgment in problem-solving.
Good to have:
- Participation/leader in quality process improvement.
- Experience with ISO 14971.
- Knowledge of basic statistics.
- ASQ certification (CQE/CQIA/CQT/CQPA).
Perks:
- Hybrid working model
- Flexible and generous vacation policy
- Maternity / Paternity Leave/ Adoption/ Commissioning leave
- Generous Medical Benefits: Above market family floater medical insurance coverage including both parents or parents-in-law
- Metro connectivity from office
- A supportive, collaborative group of people who understand that success depends on the team
4 skills required
Job Details
Why join AliveCor?
At AliveCor, we imagine a healthier world powered by access to personalized intelligent information. We're on a mission to be the world’s heart health partner by enabling access to quality heart care for everyone. AliveCor has pioneered over-the-counter medical ECG devices and continues to lead the way in empowering consumers and patients to take care of their heart. Using our FDA-cleared medical-grade hardware and software, millions of users have taken more than 200 million heart health measurements and counting.
Our vibrant team of people are attracted to AliveCor because they want to build something meaningful -- and AliveCor delivers: every day, customers tell us that we’ve saved lives. Join us in our mission!
Making the invisible visible. By harnessing the power of artificial intelligence, we’re advancing the practice of medicine for doctors and society. And we’re just getting warmed up.
The Opportunity:
AliveCor is the most clinically validated personal ECG technology, trusted and recommended by leading cardiology practices in the United States and around the world. We value research, working in collaboration with hospitals and research groups, and supporting internal research in artificial intelligence and machine learning.
In this role as Complaints Analyst, you will be part of the Quality team, responsible for ensuring that AliveCor products perform as intended and meet/exceed customer expectations. You will work closely with Quality, Regulatory, Engineering, Product Management, Clinical, and the Customer Service team to implement and maintain an ISO 13485 and FDA compliant Quality Management System, specifically in the area of Complaints Management and Post-Market Surveillance. If you have what it takes to drive change in the medical marketplace, then this is the opportunity for you. This role is on-site at our office located in Bangalore.
Role and Responsibilities:
- Manage the domestic and international product surveillance activities for medical devices, manufactured, marketed, and distributed by AliveCor.
- Utilize troubleshooting and problem-solving skills to investigate returned products. Engage with Customer Service, Engineering, Regulatory, Clinical, and our Contract Manufacturers, etc. to identify details related to complaint information and occurrence.
- Perform an initial assessment of complaints and evaluation of complaint codes.
- Evaluate, as needed, complaint documentation for completeness and consistency, and execute additional actions as necessary to close the complaint file. Evaluate all complaints that present as potential reportable events according to appropriate regulatory standards. Escalate to appropriate teams (Clinical, Regulatory, Legal, Engineering, etc.). as needed and collaborate with Regulatory on reporting of adverse events (MDRs, MDVs, etc.).
- Perform Good Faith Effort for returned products and to obtain required information for complaint assessment and evaluation.
- Develop, implement, and monitor suitable complaint investigation templates.
- Maintain procedures related to the complaints, post-market surveillance, returned product and related processes.
- Provide input to customer guides, online FAQs, etc. to improve customer experience.
- Support the generation of metrics for complaints trending.
- Participate in Risk Management activities as required based on input from complaints data, including identification of new failure modes.
- Support quality and regulatory reviews, inspections, and audits as required.
- Other duties to support the RAQA team as needed.
Qualifications and Skills:
- BS in Science or Engineering.
- 1-3 years’ experience in the Medical Device (or other regulated) industry, preferably in Quality or Regulatory. Lesser experience considered with Advanced Degree.
- Demonstrated competence documenting technical information and communicating it to others.
- Experience with appropriate domestic medical device regulations, requirements, and standards such as: FDA 21CFR Parts 820, ISO13485.
- Must be able to work under pressure to meet regulatory reporting time frames and company requirements.
- Ability to manage small projects: is organized, driven, and results-oriented.
- Demonstrates good judgment in selecting methods and techniques to acquire information and arrive at conclusions.
Preferred:
- Participation/leader in quality process improvement initiatives.
- Experience with ISO 14971.
- Knowledge of basic statistics and be able to understand, apply, analyze, synthesize and evaluate.
- ASQ certification (CQE/CQIA/CQT/CQPA or other comparable certification) desired.
Perks and benefits
We strive to make your life outside work as smooth as possible while youre at work, and we offer a long list of benefits to make that happen.
- Hybrid working model
- Flexible and generous vacation policy
- Maternity / Paternity Leave/ Adoption/ Commissioning leave
- Generous Medical Benefits: Above market family floater medical insurance coverage including both parents or parents-in-law
- Metro connectivity from office
- A supportive, collaborative group of people who understand that success depends on the team
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