Senior Quality Engineer

About the role

Support Quality Engineering Management for managing all aspects related to the design and manufacture of the company's products in compliance with the Quality Management System requirements and the regulations of the countries where the franchise distributes and sells products.

Responsibilities

• Collect and critically analyze data and make disposition decisions on nonconforming products; provide NC decisions for less experienced QEs to ensure minimal regulatory and patient risk.
• Lead failure investigations, employ systematic problem‑solving methods, and document results for nonconforming products and complaints.
• Generate health hazard evaluations (HHE) of observed NC on distributed products to determine if stop shipment and/or field action should be proposed; maintain and update risk management reports.
• Own input into the CAPA process, trend data to identify and propose CAPA opportunities, and support CAPAs either through ownership or as part of a CAPA team.
• Identify and implement improvements within the QMS.
• Support Supplier Quality with external manufacturers for escalated or larger‑scope issues, managing detected non‑conformities.
• Establish product quality control plans commensurate to product risk.
• Coordinate with Engineering to establish design verification/validation and process or software validation plans for changes or new product/process development.
• Review and provide input into process validation planning, protocols, and reports.
• Perform preliminary review of change impact assessments to confirm quality requirements are met.
• Coordinate investigations for the cause of V&V failures using root cause analysis.
• Identify opportunities for quality improvements in the production area and lead improvement plans or projects.
• Provide daily support, as needed, for complaint evaluations and investigations; support customer‑related processes involving use of the device.
• Support meeting customer quality complaint and Medical Device Report/Vigilance quality metrics.
• Develop and maintain effective relationships with internal and external stakeholders to assist customers and drive resolution of complaints.