Staff Quality Engineer

About Pacira 
Pacira BioSciences, Inc. is a leading provider of non-opioid pain management and regenerative health solutions dedicated to improving outcomes for health care practitioners and their patients. Our in-depth knowledge of non-opioid pain management, coupled with our passion for advancing patient care, drives our commitment to providing solutions that address unmet medical needs and improve clinical results.     
   
Why work with us? 
Rarely do you have an opportunity to do work that really matters. What drives us is our mission. What makes us successful are our people.  At Pacira, you are part of an inclusive culture that fosters collaboration, growth, and innovative thinking - a place where you can make an impact and help change the standard of care in non-opioid pain management. Be part of our movement, let’s pursue excellence together.  

Summary:

The Staff Quality Engineer leads and oversees the design changes for sustaining and new production introduction for the iovera medical device portfolio, championing key design change projects in alignment with the Company’s overall direction and medical device needs.

Essential Duties & Responsibilities:

The following statements are intended to describe the general nature and level of work being performed by an individual assigned to this job.  Other duties may be assigned.

• Ensure that all modifications to product designs meet regulatory and quality standards through thorough risk assessment, validation and verification processes.
• Partner with R&D on new product development through project phases, providing input on process quality requirements.
• Collaborate closely with cross-functional teams to implement design changes, ensuring compliance with industry regulations and internal quality management systems.
• Implement a risk-based remediation strategy and execute a detailed plan to address any identified gaps to ensure compliance with regulations and quality policies in all relevant markets.
• Help 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. 
• Support the Product Reliability Program or complaint investigations as needed. Assess data, support reliability strategy and initiatives, support complaint investigations, record results and summarize findings in quality records.

• When necessary, support teams interacting 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 the operations group, proactively assessing and recommending continuous process and quality improvement. Trend and report quality metrics.
• Lead/own or support CAPA investigations and CAPA closures.
• Support internal and external audits to ensure compliance with all quality standards.  Partner cross functionally to initiate corrective actions and drive root cause analysis and resolution of issues through team members and suppliers as necessary.  
• Travel may be required.

Supervisory Responsibilities:

This role has no supervisory responsibilities.

Interaction:

The incumbent works closely with various departments (e.g., QC, QA, Operations, regulatory and within R&D). 

Education and Experience:

• BS Degree or higher in life sciences, biomedical, quality or similar engineering field required
  • Electrical Engineering and Software knowledge preferred 
• 8 years’ experience in medical device design or like fields required

Knowledge, Skills, and Abilities:

• A practical and working knowledge of ISO 13485, 21 CFR 820, MDR, ISO 14971, IEC 60601-1 and 2, IEC 62304
• Experience with Design Controls, Product Development, Supplier Audits, Remediation

• Detail oriented, well organized and have excellent communication skills
• Able to manage high workload independently
• Data drive- data