• Support Device Reliability initiatives by assessing and trending field issues and collaborating with technical teams to implement device improvement projects.
• Develop and maintain documentation for manufacturing processes, CAPA, complaint investigations and trend analysis.
• Develop validation protocols to support operations.
• Support the Design and validation of test methods for evaluating product reliability.
• Provide support and oversight for the development of procedures systems and methods for inspecting and testing of finished products.
• Perform analysis of reports and production data to identify trends and recommend updates or changes to quality standards and procedures when necessary.
• Support Supplier and internal Quality Audits.
• Conduct or support quality event investigations (e.g., Complaints, NCMRs, Deviations, and CAPAs). Work cross functionally to help identify root cause and any necessary corrective actions. Initiate corrective actions and drive root cause analysis and resolution of issues with team members as necessary.
• Design Control & Product Development
• Represent Quality and lead efforts in identifying and documenting Risk Management records (Risk Management Plans, FMEAs, Hazards Analysis).
• Initiate product Quality Plans.
• Represent QA in new product development projects and design changes to existing products.
• Provide input into component and process quality requirements.
• Write/review and approve test protocols and reports and establish sampling plans.
• Provide input on design-for-quality efforts.
• Support activities related to sterilization validation and biocompatibility testing.
• Support activities related to transit validations and product shelf-life testing.

• Process/System/Tooling and Calibration

• Review Mfg/quality Process, system, equipment/tool and facility requirements and perform IQ/OQ/PQ as necessary.
• Support Preventive Maintenance/Calibration activities.

• Bachelor's degree in Science/Engineering or equivalent required, preferably in life sciences, biomedical
• Experience working in FDA GMP/ISO environment required
• Experience working in customer service and/or technical product support required
• Must have minimum 4 years' experience in a medical device company

• Must have working knowledge of CFR 820, ISO 13485, ISO 14971, IEC 60601-01
• Must have working knowledge of product reliability testing
• Have working knowledge of sterilization, biocompatibility, and transit/shelf-life standards

• Great organizational skills

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.