i'm helping qvalfocus.com find a top candidate to join their team full-time for the role of remediation complaint analyst – medical devices.

you will ensure patient safety and product quality by leading critical complaint investigations.

compensation:

inr 10 - 15/year

location:

remote (anywhere)

mission of qvalfocus.com:

"our mission is to help regulated organizations achieve operational excellence and compliance through expert guidance, structured execution, and reliable solutions that ensure quality, clarity, and lasting performance."

what makes you a strong candidate:

- you have +6 years experience in quality assurance (qa).
- you are proficient in technical documentation, regulatory compliance, data analysis, complaint management.
- english - conversational

responsibilities and more:

job summary:

- the complaint analyst is responsible for the intake, review, investigation, and documentation of product complaints in accordance with applicable regulatory requirements and internal quality procedures.
- this role supports the post-market surveillance process by ensuring timely evaluation, investigation, and closure of complaints while maintaining compliance with fda regulations, iso 13485, and other applicable quality system requirements.

key responsibilities:

- review, document, and process product complaints received from customers, field service teams, and distributors.
- perform complaint intake and ensure accurate documentation of complaint details within the complaint handling system.
- conduct initial complaint assessments to determine severity, reportability, and investigation requirements.
- perform complaint investigations including review of device history records, service records, and failure data.
- support the determination of medical device reporting (mdr) or regulatory reporting requirements when applicable.
- code complaints using appropriate complaint classification systems (e.g.,



imdrf coding).
- coordinate with cross-functional teams including quality, regulatory affairs, r&d;, manufacturing, and service to support complaint investigations.
- ensure complaints are processed and closed within established timelines and quality system requirements.
- support complaint trending activities and assist in identifying potential product quality signals.
- maintain accurate and complete documentation in compliance with fda 21 cfr part 820, iso 13485, and company procedures.
- participate in internal audits and regulatory inspections related to complaint handling processes.
- support post-market surveillance activities and provide complaint data summaries as required.

required qualifications:

- bachelor's degree in engineering, life sciences, biomedical, or related technical discipline.
- 6-10 years of experience in complaint handling, post-market surveillance, or quality assurance within a regulated industry.
- experience working within medical device or pharmaceutical quality systems is preferred.
- familiarity with fda 21 cfr part 820 and iso 13485 requirements and fda 483 remediation or eu mdr remediation.
- experience working with complaint management systems (track wise, veeva, salesforce, or similar).
- strong analytical and problem-solving skills.
- excellent documentation and technical writing abilities.

preferred qualifications:

- experience with medical device reporting (mdr) or vigilance reporting.
- knowledge of imdrf complaint coding.
- exposure to capa processes and root cause analysis.
- experience supporting post-market surveillance activities.
- familiarity with regulatory requirements including fda, eu mdr, and general vigilance reporting.

key skills:

- complaint investigation and documentation.
- regulatory compliance and quality systems.
- data analysis and complaint trending.
- cross-functional collaboration.
- technical documentation and reporting.

your potential leader:

- raj

📌 Remediation complaint analyst - medical devices (Xico)
🏢 Emma of Torre.ai
📍 Xico