• Making a difference in our products, services and offers, never ceasing to fight for groundbreaking solutions in everything we do;
• Making a difference in how we work and collaborate, constantly nurturing our nimble culture of innovation;
• Having an impact on the healthcare challenges we all face, and the lives of people and communities around the world.

CAPA Management

• Act as a subject matter expert (SME) for CAPA, non-conforming product, deviations (quality non-conformance) and compliance-related activities.
• Lead the end-to-end CAPA, non-conforming product and deviations (quality non-conformance) processes, including initiation, investigation, root cause analysis, action planning, implementation, and effectiveness verification.
• Ensure CAPA activities are compliant with applicable regulations (e.g., FDA 21 CFR Part 820, ISO 13485, EU MDR).
• Review and approve CAPA records to ensure completeness, accuracy, and timeliness. Coordinates CAPA Review Board, publish meeting minutes and ensures actions are completed on a timely manner.
• Monitor CAPA metrics and quality data sources trends to identify systemic issues and drive continuous improvement. Owns and/or supports the quality data trending process.
• Facilitate cross-functional CAPA review meetings and provide guidance on investigation techniques and problem-solving methodologies. Facilitates CAPA and lead-instructor / in-person QMS compliance training
• Implement and promote best practices in root cause analysis (e.g., 5 Whys, Fishbone, Fault Tree Analysis).
• Analyze quality data and trends to proactively identify risks and opportunities.

Compliance & Quality Systems

• Drive improvements in quality system processes, particularly CAPA effectiveness and timeliness.
• Maintain compliance with global regulatory requirements and internal quality management system (QMS) procedures.
• Support internal and external audits, including FDA inspections, notified body audits, and customer audits.
• Lead or support responses to audit findings, including CAPA development and implementation.
• Ensure inspection readiness and support regulatory submissions as needed.

• Bachelor’s degree in engineering, Life Sciences, or a related technical field required.

• Minimum of 5 years of experience in quality systems within the medical device or regulated industry.

• Strong experience managing CAPA systems and regulatory compliance activities.

• Strong data analysis and trending skills, with the ability to interpret complex quality data, identify patterns, and drive data-driven decision-making.

• Comprehensive knowledge of FDA QSR, ISO 13485, EU MDR, and related quality system regulations and standards.

• Strong understanding of root cause analysis tools and risk management principles.

• Personnel performing work affecting product quality shall be competent based on appropriate education, training, skills and experience.

• Master’s degree preferred.

• 7+ years of experience in quality systems, quality engineering, or regulatory compliance within a regulated industry (medical device, pharmaceutical, etc.).

• 2+ years of leadership or management experience in a quality systems role.

• Demonstrated success in leading quality system audits, managing CAPAs, and resolving complex quality issues.

• Exceptional leadership, interpersonal, and communication skills with the ability to influence at all levels of the organization.

• Proficient in eQMS platforms (e.g., TrackWise, MasterControl, ETQ) and Microsoft Office Suite.

• Lean Six Sigma certification (Green Belt or higher).