Quality Complaint Investigator

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.

Responsibilities:

1. Receive and triage complaints and product-related information from the Customer Support Center in accordance with established procedures.
2. 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.
3. Accurately document, classify, and enter complaint data into the eQMS, ensuring completeness and data integrity.
4. 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.
5. 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.
6. Coordinate with cross-functional departments (e.g., Quality, Engineering, Regulatory, Manufacturing) to support complaint evaluation, investigation activities, and closure actions.
7. Ensure timely and compliant processing of complaints in accordance with established QMS procedures and regulatory timelines.
8. Support preparation and submission of medical device event reports to regulatory authorities and government agencies, as required.
9. 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.
10. Collaborate in root cause investigations and participate in Corrective and Preventive Action (CAPA) activities, as applicable.
11. Coordinate return goods processes to ensure proper handling, traceability, and investigation of returned product.
12. Support internal and external audits and regulatory inspections, including preparation of complaint records and supporting documentation.
13. Contribute to post-market surveillance reports through data collection, analysis, and documentation of complaint trends.
14. Perform other duties as assigned in support of the Quality Management System.

Supervisory Responsibilities:

This person has no direct supervisor responsibilities.

Education and Experience:

• Minimum 5 years of relevant Pharmaceutical/Medical Device Industry Quality Assurance experience required
• BS/BA degree in scientific discipline desirable

Qualifications:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

Knowledge, Skills, and Abilities:

1. Knowledge of QSR's and their application
2. Complaint handling experience
3. Ability to work proactively and cooperatively with managers and operational staff to solve quality problems
4. Ability to manage multiple responsibilities with a high degree of self motivation
5. Good written, oral, and interpersonal English communication skills
6. Ability to use Microsoft Word and Excel applications
7. Data integrity and ALCOA principles application in quality systems
8. Advanced technical writing and regulatory documentation proficiency
9. Data trending and statistical data interpretation for quality signals

Work Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

Typical office setting, cubicles, noise level is moderate with consistent printer, telephone ringing and conversation. The work environment also includes warehouse and manufacturing areas.

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to sit, talk, move between spaces, reach with hands and arms and stoop. Close vision and the need to focus on computer screen, use of hands, fingers and wrist to type on keyboard and manipulate mouse.

• 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

The base pay range for this role is $72,000 to $100,000 per year. The range is what we reasonably expect to pay for this role. The range considers a wide range of factors that are considered in making compensation decisions, including but not limited to: geographic markets, business or organizational needs, skill sets, experience, training, licensure, and certifications. Depending on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered.

EEO Statement: Pacira is proud to be an Equal Opportunity Employer and does not discriminate against applicants because of race, color, religion, sex (including gender identity, sexual orientation, and pregnancy), national origin, age (40 or older), veteran status, disability or genetic information, or any other characteristic protected under applicable federal, state, or local law. At Pacira we are committed to intentionally cultivating a culture of inclusion where all feel welcomed and valued for their background, perspectives, and experiences. We hold one another accountable to promote trust and transparency in support of our communities and collective purpose.
Agency Disclaimer: Pacira Biosciences, Inc. (Hereafter, Pacira) does not accept unsolicited resumes from recruiters or employment agencies in response to the Pacira Careers page or a Pacira social media post. Pacira will not consider or agree to payment of any referral compensation or recruiter fee relating to unsolicited resumes. Pacira explicitly reserves the right to hire said candidate(s) without any financial obligation to the recruiter or agency. Any unsolicited resumes, including those submitted to hiring managers, are deemed to be the property of Pacira.