Senior QA Leader – Medical Devices & Compliance

Symmetrio; South Carolina; On-site; USD 90,000 - 130,000; Full time

Job summary

Symmetrio is recruiting a Senior Quality Assurance Specialist for a growing medical device company in Richland, WA. The role provides quality oversight across the design, manufacturing, testing and release of regulated medical devices.

The Senior QA 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.

Qualifications

• 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 in the medical device or pharmaceutical industry.
• Working knowledge of FDA 21 CFR requirements, ISO 13485, and MDSAP.
• Good Manufacturing Practices (GMP) 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.

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.

Skills

Root-cause analysis

CAPA management

Problem-solving

Process improvement

Documentation

Communication skills

Cross-functional collaboration

Auditing

Microsoft Office

Education

Bachelor's degree in life sciences, engineering, or related field

Tools

Electronic QMS

Job description

Symmetrio is recruiting a Senior Quality Assurance Specialist for a growing medical device company in Richland, WA. The role provides quality oversight across the design, manufacturing, testing and release of regulated medical devices.

The Senior QA 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.