Director, Global Quality and Compliance

Job Title: Director, Global Quality and Compliance

 

Role Level: People Manager

 

Supervisor/Manager Title: Vice President Quality and Compliance

 

Job Location & Environment: Irvine, CA – Corporate Office

 

Job Description Summary: The Director, Global Quality and Compliance is a senior leadership role responsible for defining and executing the enterprise QMS strategy, governance, and performance framework to ensure a scalable, compliant, and inspection ready quality system across the organization. This role provides end to end accountability for the effectiveness and continuous improvement of core QMS processes, including CAPA, nonconformance, change control, document control, training, management review, quality metrics, and regulatory inspection readiness.

 

The Director partners closely with cross functional stakeholders to embed quality system requirements into business processes and product lifecycle activities, while proactively identifying and mitigating compliance risks. This leader drives enterprise-wide QMS transformation, harmonization, and digital quality initiatives, ensuring alignment with global regulatory requirements (FDA 21 CFR 820 & 21 CFR 812, ISO 13485, EU MDR, MDSAP) and business objectives.

 

This position requires a proven leader capable of influencing strategic decision making, leading through regulatory inspections and remediation, and building and developing high-performing teams to sustain long-term quality and compliance excellence in a complex, highly regulated medical device

 

Job Responsibilities: 

QMS Development & Implementation

• Develop, maintain and enhance JenaValve’s Quality Management System to ensure alignment with business objectives, global regulatory requirements, and industry standards.
• Ensure that the Corporate QMS aligns with organizational objectives and integrates with all functional areas effectively
• Provide enterprise leadership and accountability for core QMS processes, including CAPA, nonconformance management, change control, document control, training, management review, quality metrics and trending, and inspection readiness.
• Sponsor digital quality and eQMS strategy, including system enhancements, implementation priorities, and validation oversight for systems supporting regulated processes.
• Partner with executive and functional leaders to embed QMS requirements into business processes and product lifecycle activities.

Leadership and Training

• Lead QMS transformation, remediation, and harmonization initiatives across sites and functions to build a scalable, efficient, and inspection-ready quality system.
• Build, lead, and develop a high-performing QMS organization, including succession planning, capability building, and leadership development.

Quality Assurance and Compliance

• Stay updated on international quality standards and regulatory requirements relevant to the medical device industry.
• Champion improvement initiatives by working with teams to establish effective quality plans
• Employ statistical techniques and data analysis tools to inform decision-making and promote efficiency
• Drive the development of KPIs to measure the QMS effectiveness.

Audit Management

• Serve as the senior quality systems leader for internal audits, external audits, customer audits, notified body audits, and regulatory inspections, including organizational readiness, response strategy, and sustainable corrective action execution.
• Analyze audit findings, identify trends, and develop corrective action actions to prevent reoccurrence of issues.

Risk Management

• Establish and monitor quality system KPIs, trends, and risk indicators, and communicate quality system performance, risks, and priorities to senior leadership.
• Lead management review strategy and governance mechanisms, ensuring timely escalation of systemic issues, compliance risks, and organizational priorities.

Required Education and Experience: 

• Bachelor’s degree in engineering, Life Sciences, Quality, Regulatory Affairs, or a related technical discipline required; Master’s degree preferred.
• Minimum of 12 years of progressive experience in Quality Assurance, Quality Systems, or Quality Compliance within a regulated medical device, IVD, or life sciences environment.
• Minimum of 7 years of people leadership experience, including direct management of managers and leadership of cross-functional or enterprise quality system initiatives.
• Demonstrated experience owning or leading enterprise level QMS processes and governance within a complex, highly regulated environment.
• Deep working knowledge of FDA 21 CFR Part 820, ISO 13485, EU MDR, MDSAP, and other applicable global quality system requirements.
• Proven track record leading regulatory inspections, external audits, QMS remediation efforts, and large scale quality system transformation initiatives.
• Experience influencing stakeholders and driving cross functional alignment on compliance, risk, and quality system priorities.
• Strong analytical, communication, organizational, and decision-making skills with the ability to operate effectively in a fast-paced, growth oriented environment.

 

Skills and Abilities Required for This Job: 

• Experience in global or multi site Quality Management System leadership within a complex regulated organization.
• Demonstrated success leading enterprise QMS harmonization, remediation, inspection readiness, or business transformation initiatives.
• Experience with electronic quality systems (eQMS), validation activities, and digital quality transformation.
• Experience supporting product portfolios subject to FDA, EU, and other international regulatory requirements.
• Lead Auditor, Certified Quality Auditor (CQA), RAC, ASQ, or equivalent quality/regulatory certifications preferred.
• Experience within innovation driven, high growth, or pre and post remediation medical device organizations preferred.

 

Physical Requirements: 

• Travel Domestic and International 25%