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.

Responsibilities

• 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.

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 experience.
• Experience within the medical device or pharmaceutical industry.
• Working knowledge of FDA 21 CFR requirements, ISO 13485, and MDSAP.
• Good Manufacturing Practices certification.
• Experience managing nonconformance investigations and CAPA processes.
• Strong knowledge of quality systems, manufacturing controls, and regulatory compliance.
• Experience supporting internal audits, regulatory inspections, or notified-body audits.
• Strong root-cause analysis, problem-solving, and process-improvement skills.
• Excellent documentation, organization, and attention to detail.
• Ability to interpret standard operating procedures and work instructions.
• Strong written and verbal communication skills.
• Ability to work effectively with cross-functional teams and manage multiple deadlines.
• Proficiency with Microsoft Outlook, Word, Excel, and PowerPoint.
• Experience working in a radiologically controlled environment is preferred.
• Ability to work a flexible schedule and travel as needed.
• Ability to successfully complete required background and drug screenings.