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, independently lead internal audit activities, monitor quality performance indicators, identify compliance gaps and drive quality-system improvements, and help strengthen the organization’s quality management system. This is a senior individual contributor role requiring the ability to independently manage quality programs and work cross-functionally to improve processes and compliance.

Responsibilities

• Serve as the primary quality contact for manufacturing-related nonconformance and CAPA activities.
• Review and lead 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, identify trends and compliance gaps and present findings to management and cross-functional stakeholders.
• Independently plan, develop, conduct, document, and follow up on internal process and quality-system audits.
• 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, identifying opportunities for improvement where appropriate.
• Identify, develop, and implement improvements to manufacturing quality, compliance, and quality-system processes.
• 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.

Requirements

• Bachelor’s degree in life sciences, engineering, or a related field, or an equivalent combination of education and experience.

• At least eight years of quality assurance, quality engineering, or quality systems experience