Manager, Quality Complaints
Pacira BioSciences, Inc.
5 hours ago
On-site
San Diego, CA
Operations
Purpose:
- Responsible for quality processes for product complaint handling, procedures, and controls to ensure complaints are processed per company procedures and worldwide regulations/standards.
Responsibilities:
- Manage end-to-end complaint handling: intake, follow-ups, evaluation, investigation, resolution.
- Review incoming communications (calls/emails) and support technical root cause analysis (design/device performance).
- Assess reportability under applicable regulations (e.g., FDA 21 CFR Part 803, EU MDR, CMDR, MHRA); obtain adequate information for documentation, testing/log analysis, and closure with regulatory justifications.
- Collaborate cross-functionally (R&D, manufacturing, customer service) to investigate/resolve complaints.
- Perform statistical trending for symptom codes/root causes (IMDRF Appendix A/D); use visualization and statistical methods (Pareto, control charts, regression).
- Ensure compliance with global regulatory requirements (FDA, ISO 13485, CMDR, MHRA, EU MDR); manage/report MDRs or Vigilance Reports; interface with Notified Bodies as required.
- Maintain complaint records in electronic QMS/database; perform trend analysis and initiate CAPAs; conduct risk assessments and support Health Hazard Evaluations (HHE) as needed.
- Support audits/inspections with complaint documentation.
- Improve complaint handling process and develop training; perform additional duties as assigned.
Qualifications:
- BS in Systems/Mechanical/Electrical/Software/Biomedical Engineering (or related) highly desirable; MS preferred.
- 8+ years in relevant Systems, Software, Mechanical design, or related experience required.
Skills/Abilities:
- Strong analytical/problem-solving; excellent written/verbal communication; cross-functional collaboration; manage multiple priorities/self-motivated.
- Knowledge of QSRs; proactive quality problem-solving.
- Proficient in Microsoft Office Suite with advanced Excel (data analysis/reporting).
Benefits:
- Medical, dental, vision; FSA/HSA (company match); EAP; mental health resources; disability and life insurance; critical illness/accident; legal/identity theft protection; pet insurance; fertility/maternity assistance; 401(k) with match; flexible time off and 11 paid holidays; paid parental leave.
- Responsible for quality processes for product complaint handling, procedures, and controls to ensure complaints are processed per company procedures and worldwide regulations/standards.
Responsibilities:
- Manage end-to-end complaint handling: intake, follow-ups, evaluation, investigation, resolution.
- Review incoming communications (calls/emails) and support technical root cause analysis (design/device performance).
- Assess reportability under applicable regulations (e.g., FDA 21 CFR Part 803, EU MDR, CMDR, MHRA); obtain adequate information for documentation, testing/log analysis, and closure with regulatory justifications.
- Collaborate cross-functionally (R&D, manufacturing, customer service) to investigate/resolve complaints.
- Perform statistical trending for symptom codes/root causes (IMDRF Appendix A/D); use visualization and statistical methods (Pareto, control charts, regression).
- Ensure compliance with global regulatory requirements (FDA, ISO 13485, CMDR, MHRA, EU MDR); manage/report MDRs or Vigilance Reports; interface with Notified Bodies as required.
- Maintain complaint records in electronic QMS/database; perform trend analysis and initiate CAPAs; conduct risk assessments and support Health Hazard Evaluations (HHE) as needed.
- Support audits/inspections with complaint documentation.
- Improve complaint handling process and develop training; perform additional duties as assigned.
Qualifications:
- BS in Systems/Mechanical/Electrical/Software/Biomedical Engineering (or related) highly desirable; MS preferred.
- 8+ years in relevant Systems, Software, Mechanical design, or related experience required.
Skills/Abilities:
- Strong analytical/problem-solving; excellent written/verbal communication; cross-functional collaboration; manage multiple priorities/self-motivated.
- Knowledge of QSRs; proactive quality problem-solving.
- Proficient in Microsoft Office Suite with advanced Excel (data analysis/reporting).
Benefits:
- Medical, dental, vision; FSA/HSA (company match); EAP; mental health resources; disability and life insurance; critical illness/accident; legal/identity theft protection; pet insurance; fertility/maternity assistance; 401(k) with match; flexible time off and 11 paid holidays; paid parental leave.