Complaints Analyst
Complaints Analyst
Posted on :
20-05-2025
Employer Active
1 Vacancy
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Job Description
Why join AliveCor
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 weve saved lives. Join us in our mission!
Making the invisible visible. By harnessing the power of artificial intelligence were advancing the practice of medicine for doctors and society. And were 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 PostMarket Surveillance. If you have what it takes to drive change in the medical marketplace then this is the opportunity for you. This role is onsite 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 problemsolving 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 postmarket 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.
- 13 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 resultsoriented.
- 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 parentsinlaw
- Metro connectivity from office
- A supportive collaborative group of people who understand that success depends on the team
Required Experience:
IC
Employment Type
Full-Time
Department / Functional Area
Key Skills
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