Job Description
Job Description
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.
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.