Sr. Staff Quality Engineer, iovera
Pacira BioSciences, Inc.About the role
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 Senior Staff Quality Engineer leads and oversees design changes for both sustaining and new product introductions within the iovera° medical device portfolio, driving critical design change projects in alignment with the company’s strategic objectives and medical device requirements. The position is responsible for delivering electrical and software engineering innovation and expertise in the design and development of complex, handheld, battery-powered electro-mechanical medical devices and their associated accessories. In this role, you will serve as the primary technical contributor and quality representative, ensuring compliance with the Quality Management System (QMS) as well as company regulations, standards, and applicable guidance. Expected to mentor, coach and provide technical guidance to junior Engineering staff members.
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 Compliance with Design Standards: Oversee modifications to product designs, ensuring all changes meet regulatory and quality standards through comprehensive risk assessments, and validation and verification processes.· Collaborate on New Product Development: Partner closely with R&D throughout the new product development lifecycle, providing critical input on quality requirements to ensure product and process compliance.· Drive Cross-Functional Collaboration: Work closely with cross-functional teams to implement design changes, ensuring alignment with industry regulations and adherence to internal Quality Management Systems (QMS).· Risk-Based Remediation: Develop and implement risk-based remediation strategies, executing detailed plans to close any identified compliance gaps with regulations and quality policies across all relevant markets.· Foster a Culture of Excellence: Promote and uphold a culture of excellence, integrity, and patient safety, ensuring management systems are in place to support these principles.· Support Product Reliability & Investigations: Contribute to the Product Reliability Program and complaint investigations, analyzing data, supporting reliability strategies, documenting results, and summarizing findings in quality records.· Regulatory Agency Interaction: Collaborate with regulatory agencies (FDA, Notified Bodies, Foreign Regulatory Agencies) to address and resolve compliance issues. Assist cross-functional teams in preparing regulatory filings such as 510(k) notifications, IDE correspondence, and technical dossiers.· Process & Quality Improvement: Partner with the operations team to proactively assess and recommend continuous process and quality improvements, while monitoring and reporting key quality metrics.· Lead and Support CAPA Investigations: Lead or support CAPA (Corrective and Preventive Action) investigations and closures, ensuring thorough root cause analysis and resolution.· Audit Support: Support both internal and external audits to maintain compliance with quality standards. Collaborate across teams to initiate corrective actions and ensure timely resolution of audit findings.· 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 Experi
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