Quality Complaint Investigator

Pacira Pharmaceuticals, Inc.•San Diego, CA

23h•$72,000 - $100,000

About The Position

At Pacira, innovation meets purpose. Pacira BioSciences, Inc. is a pioneer in non-opioid pain management and regenerative health solutions. Today, we’re building on that legacy with next-generation innovations for chronic, postsurgical, and musculoskeletal pain. Our culture is built on collaboration, innovation, and a shared commitment to helping patients recover faster. We are redefining what’s possible in pain management—and we can’t do it without talented people like you. Why Join Us? At Pacira, every career is more than a job. Our mission drives us, and every day, we challenge ourselves to achieve the extraordinary. Integrity is at the core of who we are. We value diverse perspectives and the collective strength of a unified team. Join the team in making better possible for patients everywhere Purpose: This role is responsible for the intake, evaluation, and formal investigation of product complaints in compliance with the Quality Management System Regulation (QMSR), 21 CFR Part 820, ISO 13485:2016, FDA Medical Device Reporting (21 CFR Part 803) EU Medical Device Regulation (EU MDR 2017/745, and applicable global regulatory requirements. This role ensures timely and accurate complaint handling, including classification, coding, root cause analysis, and determination of reportability for regulatory submissions. The position also supports post-market surveillance, trend analysis, CAPA activities, and regulatory inspections.

Requirements

Minimum 5 years of relevant Pharmaceutical/Medical Device Industry Quality Assurance experience required
BS/BA degree in scientific discipline desirable
Knowledge of QSR’s and their application
Complaint handling experience
Ability to work proactively and cooperatively with managers and operational staff to solve quality problems
Ability to manage multiple responsibilities with a high degree of self motivation
Good written, oral, and interpersonal English communication skills
Ability to use Microsoft Word and Excel applications
Data integrity and ALCOA+ principles application in quality systems
Advanced technical writing and regulatory documentation proficiency
Data trending and statistical data interpretation for quality signals

Responsibilities

Receive and triage complaints and product-related information from the Customer Support Center in accordance with established procedures.
Lead and execute formal complaint investigations by exercising independent judgment in the evaluation of product-related issues, including critical review of associated records, determination of root cause, and assessment of product impact, ensuring conclusions are scientifically sound, well-documented, and aligned with regulatory and Quality Management System requirements.
Accurately document, classify, and enter complaint data into the eQMS, ensuring completeness and data integrity.
Exercise independent judgment in the assignment and verification of symptom codes, root cause codes, and product impact classifications, ensuring alignment with internal procedures, regulatory requirements, and investigation outcomes to support accurate trending, risk evaluation, and regulatory decision-making.
Exercise independent judgment in performing reportability assessments to determine regulatory submission requirements (e.g., MDR/Vigilance) in accordance with applicable global regulations; escalate to Medical Affairs and/or Clinical for further evaluation when medically or clinically warranted. Ensure appropriate assignment and verification of symptoms and root cause coding to support accurate regulatory decision-making.
Coordinate with cross-functional departments (e.g., Quality, Engineering, Regulatory, Manufacturing) to support complaint evaluation, investigation activities, and closure actions.
Ensure timely and compliant processing of complaints in accordance with established QMS procedures and regulatory timelines.
Support preparation and submission of medical device event reports to regulatory authorities and government agencies, as required.
Independently analyze and interpret complaint data, metrics, and trend information to identify potential signals, emerging risks, or systemic issues; exercise judgment in escalating significant trends to management and cross-functional stakeholders to support post-market surveillance, risk management, and continuous improvement activities.
Collaborate in root cause investigations and participate in Corrective and Preventive Action (CAPA) activities, as applicable.
Coordinate return goods processes to ensure proper handling, traceability, and investigation of returned product.
Support internal and external audits and regulatory inspections, including preparation of complaint records and supporting documentation.
Contribute to post-market surveillance reports through data collection, analysis, and documentation of complaint trends.
Perform other duties as assigned in support of the Quality Management System.