Senior Quality Assurance Specialist

Senior Quality Assurance Specialist

Symmetrio is recruiting a Senior Quality Assurance Specialist for a growing medical device company in Richland, Washington.

This position will provide quality oversight across the design, manufacturing, testing, and release of regulated medical devices. The Senior Quality Assurance Specialist will manage nonconformance and CAPA activities, support internal and external audits, monitor quality performance indicators, and help strengthen the organization's quality management system.

• Serve as the primary quality contact for manufacturing-related nonconformance and CAPA activities.
• Review investigations for appropriate problem statements, root-cause analysis, corrections, and corrective or preventive actions.
• Maintain NC and CAPA records within the electronic quality management system.
• Ensure compliance with FDA 21 CFR requirements, ISO 13485, MDSAP, and other applicable standards.
• Track quality performance indicators and present findings to management and cross-functional stakeholders.
• Develop and conduct internal process audits.
• Support notified-body audits and FDA inspections as a quality subject-matter expert.
• Review and approve validation protocols, calibration records, analytical reports, and equipment maintenance records.
• Monitor process controls, supplier quality, and product conformity.
• Develop and improve manufacturing quality and compliance processes.
• Provide quality-system training and support to team members.
• Lead the resolution of quality issues involving manufacturing, operations, and support teams.
• Perform additional quality-related responsibilities as assigned.