Summary Responsible for maintaining and improving the Quality Management System (QMS) to ensure compliance with medical device regulations (ISO 13485, FDA, EU MDR). Leads QMS effectiveness, CAPA processes, audits, and continuous improvement initiatives while partnering cross-functionally to uphold product quality and regulatory standards.
Key Responsibilities
QMS Management & Improvement
Manage day-to-day QMS operations to ensure compliance with global regulatory standards
Lead Quality Management Review (QMR) process, including data collection and reporting
Drive continuous improvement initiatives to enhance QMS effectiveness
Develop and maintain SOPs, work instructions, and controlled documentation
Regulatory Compliance & Audits
Prepare for and support internal/external audits and regulatory inspections
Coordinate audit activities, documentation, and responses
Track audit findings and ensure timely corrective actions
Documentation & Reporting
Maintain compliant documentation and records management systems
Generate reports on QMS performance, audit outcomes, and compliance metrics
Monitor and report key quality performance indicators
CAPA & Non-Conformance
Lead CAPA process, including investigation, root cause analysis, and effectiveness checks
Manage non-conformance reporting and resolution
Guide teams through quality processes and ensure timely closure of issues
Cross-Functional Support
Partner with R&D, Manufacturing, Regulatory, and Supply Chain on quality initiatives
Provide QMS and regulatory guidance across teams
Qualifications
Bachelor’s degree in Engineering, Science, Nursing, or related field
5+ years in Quality Assurance, including 3+ years in medical device QMS
Strong knowledge of ISO 13485, FDA 21 CFR Part 820, EU MDR, and ISO 14971
Experience with audits, CAPA, and regulatory inspections
Proficiency with QMS tools (e.G., MasterControl, Veeva) preferred
Certifications (CQE, CQA) a plus
Skills
Strong analytical, problem-solving, and root cause analysis capabilities
Excellent communication and cross-functional collaboration skills
Detail-oriented with strong organizational and project management abilities
Self-driven with a focus on continuous improvement
About the Company
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Peyton Resource Group
Established in 2001, Peyton Resource Group is a solution-based staffing company that matches businesses with top talent for short-term, long-term or permanent needs.
People are a business’s most valuable asset. Peyton Resource Group is dedicated to helping companies find the best talent, matching professionals with jobs where they will thrive.
With locations in Dallas/Fort Worth, San Antonio and Austin, we are available to serve your staffing needs throughout Texas and across the country.