Quality Complaint Investigator
Pacira BioSciences, Inc.
6 hours ago
On-site
San Diego, CA
Operations
Purpose:
- Responsible for the intake, evaluation, and formal investigation of product complaints in compliance with QMSR (21 CFR Part 820), ISO 13485:2016, FDA Medical Device Reporting (21 CFR Part 803), EU MDR (EU 2017/745), and applicable global regulatory requirements.
- Ensures timely/accurate complaint handling, including classification, coding, root cause analysis, and reportability determination; supports post-market surveillance, trend analysis, CAPA, and regulatory inspections.
Responsibilities:
- Receive and triage complaints and product-related information from the Customer Support Center.
- Lead formal complaint investigations using independent judgment (record review, root cause determination, product impact assessment) with scientifically sound, well-documented conclusions aligned to regulatory/QMS requirements.
- Document, classify, and enter complaint data into the eQMS with completeness and data integrity.
- Assign/verify symptom codes, root cause codes, and product impact classifications for accurate trending, risk evaluation, and regulatory decisions.
- Perform reportability assessments (e.g., MDR/Vigilance); escalate to Medical Affairs and/or Clinical when medically/clinically warranted.
- Coordinate with cross-functional teams (Quality, Engineering, Regulatory, Manufacturing) for complaint evaluation, investigation, and closure actions.
- Process complaints timely and compliantly per QMS procedures and regulatory timelines.
- Support preparation/submission of medical device event reports to regulatory authorities.
- Analyze/interpret complaint data, metrics, and trends; escalate significant trends to management and stakeholders.
- Participate in root cause investigations and CAPA activities.
- Coordinate return goods processes for proper handling, traceability, and returned product investigation.
- Support internal/external audits and regulatory inspections (complaint records and documentation).
- Contribute to post-market surveillance reports by collecting, analyzing, and documenting complaint trends.
Qualifications:
- Minimum 5 years of relevant Pharmaceutical/Medical Device Industry Quality Assurance experience (required).
- BS/BA in scientific discipline (desirable).
- Knowledge of QSRs; complaint handling experience.
- Proactive, collaborative approach to solving quality problems.
- Ability to manage multiple responsibilities; self-motivated.
- Strong written/oral/interpersonal English communication.
- Proficiency in Microsoft Word and Excel.
- Data integrity and ALCOA+ principles.
- Advanced technical writing and regulatory documentation skills.
- Data trending and statistical interpretation for quality signals.
Benefits:
- Medical, Prescription, Dental, Vision Coverage
- Flexible Spending Account & Health Savings Account with Company match
- Employee Assistance Program; Mental Health Resources
- Disability Coverage
- Life insurance
- Critical Illness and Accident Insurance
- Legal and Identity Theft Protection
- Pet Insurance
- Fertility and Maternity Assistance
- 401(k) with company match
- Flexible Time Off (FTO) and 11 paid holidays
- Paid Parental Leave
- Responsible for the intake, evaluation, and formal investigation of product complaints in compliance with QMSR (21 CFR Part 820), ISO 13485:2016, FDA Medical Device Reporting (21 CFR Part 803), EU MDR (EU 2017/745), and applicable global regulatory requirements.
- Ensures timely/accurate complaint handling, including classification, coding, root cause analysis, and reportability determination; supports post-market surveillance, trend analysis, CAPA, and regulatory inspections.
Responsibilities:
- Receive and triage complaints and product-related information from the Customer Support Center.
- Lead formal complaint investigations using independent judgment (record review, root cause determination, product impact assessment) with scientifically sound, well-documented conclusions aligned to regulatory/QMS requirements.
- Document, classify, and enter complaint data into the eQMS with completeness and data integrity.
- Assign/verify symptom codes, root cause codes, and product impact classifications for accurate trending, risk evaluation, and regulatory decisions.
- Perform reportability assessments (e.g., MDR/Vigilance); escalate to Medical Affairs and/or Clinical when medically/clinically warranted.
- Coordinate with cross-functional teams (Quality, Engineering, Regulatory, Manufacturing) for complaint evaluation, investigation, and closure actions.
- Process complaints timely and compliantly per QMS procedures and regulatory timelines.
- Support preparation/submission of medical device event reports to regulatory authorities.
- Analyze/interpret complaint data, metrics, and trends; escalate significant trends to management and stakeholders.
- Participate in root cause investigations and CAPA activities.
- Coordinate return goods processes for proper handling, traceability, and returned product investigation.
- Support internal/external audits and regulatory inspections (complaint records and documentation).
- Contribute to post-market surveillance reports by collecting, analyzing, and documenting complaint trends.
Qualifications:
- Minimum 5 years of relevant Pharmaceutical/Medical Device Industry Quality Assurance experience (required).
- BS/BA in scientific discipline (desirable).
- Knowledge of QSRs; complaint handling experience.
- Proactive, collaborative approach to solving quality problems.
- Ability to manage multiple responsibilities; self-motivated.
- Strong written/oral/interpersonal English communication.
- Proficiency in Microsoft Word and Excel.
- Data integrity and ALCOA+ principles.
- Advanced technical writing and regulatory documentation skills.
- Data trending and statistical interpretation for quality signals.
Benefits:
- Medical, Prescription, Dental, Vision Coverage
- Flexible Spending Account & Health Savings Account with Company match
- Employee Assistance Program; Mental Health Resources
- Disability Coverage
- Life insurance
- Critical Illness and Accident Insurance
- Legal and Identity Theft Protection
- Pet Insurance
- Fertility and Maternity Assistance
- 401(k) with company match
- Flexible Time Off (FTO) and 11 paid holidays
- Paid Parental Leave