• Provide strategic direction and guidance to Executive Management regarding quality timelines for new and revised products and/or processes, and/or regulations & guidances.
• Provide executive responsibility, leadership and expertise in maintenance of quality management system (ISO 13485 Certification including CMDCAS, MDD compliance and 21 CFR 820 compliance).
• Foster a culture of excellence, professional integrity and respect for patient safety. Ensure that all necessary management systems are in place to make these high principles actionable and assure the compliant practices that will result in the Company's ultimate medical and commercial success.
• Provide Quality oversight of any contract manufacturing organizations supporting iovera.
• Host, participate in and lead when necessary all external audits with Notified Bodies, FDA, etc..Respond to all corrective actions in a timely manner and drive all issues to closure.
• When necessary, interact with FDA/Notified Bodies/ Foreign Regulatory agencies to address and resolve issues. Work with cross-functional teams in preparation of regulatory filings, including 510(k) notifications, IDE correspondence, Technical Dossiers, etc.
• Internally partner with Operations group, providing quality oversight of manufacturing line, tooling and calibration programs, material review board management and release of clinical and commercial product.Trend and report quality metrics.
• Measure and report on Product Reliability Programs and the impact on customer satisfaction and adoption. Compile data, tracking and trending corrective actions, and partner with Manufacturing and/or R&D to recommend and drive product improvement projects to resolution consistent with company objectives.
• Partner with R&D on new product development through project phases, providing input on process quality requirements.
• Gather information, provide detailed reporting and provide management with key updates, including Management Review.
• Conduct internal and external audits to ensure compliance with all quality standards. Initiate corrective actions and drive root cause analysis and resolution of issues through team members and suppliers as necessary.
• Assume responsibility for CAPA program (including customer complaints), audit program and training compliance throughout the organization.
• Develop and drive team and company quality goals and objectives.
• Assume budgetary responsibility for all of quality.
• Travel may be required.

• BS Degree or higher in life sciences, biomedical, quality or similar engineering field required
• 8 years experience in medical device design and manufacturing environment required

• A practical and working knowledge of ISO 13485, 21 CFR 820, CMDCAS, MDD
• Experience with Design Controls, Product Development, Day to day management QMS
• Detail oriented, well organized and have excellent communication skills
• Able to manage internal quality team and work well with cross-functional team and all levels of the organization
• Able to accomplish objectives with minimal supervision

• 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

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.