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
- Experience within the medical device, pharmaceutical, or another regulated industry. Medical device experience is preferred
- Working knowledge of FDA 21 CFR requirements, ISO 13485, and MDSAP. Experience with ISO 9001 or other applicable quality standards will also be considered.
- Good Manufacturing Practices certification.
- Experience independently managing nonconformance investigations and CAPA processes.
- Strong knowledge of quality systems, manufacturing controls, and regulatory compliance. Demonstrated ability to identify quality-system gaps and implement process improvements.
- Experience independently planning and conducting internal audits or managing an internal audit program, along with experience supporting regulatory inspections, notified-body audits, or other external assessments
- 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 independently manage multiple quality initiatives and deadlines.
- Proficiency with Microsoft Outlook, Word, Excel, and PowerPoint.
- Experience working in a radiologically controlled environment is preferred.
- Ability to work onsite in Richland, Washington, with occasional flexibility to work from home as business needs permit, and travel as needed.
- Ability to successfully complete required background and drug screenings.
Benefits
- Health Care Plan (Medical, Dental & Vision)
- Retirement Plan (401k)
- Paid Time Off (Vacation, Sick & Public Holidays)