Director, Site Quality Operations

Job Title: Director, Site Quality Operations (Valve Manufacturing & Delivery Systems)

Role Level: People Manager

Supervisor/Manager Title: Vice President Quality and Compliance

Job Location & Environment: Irvine, CA – Corporate Office Environment

Job Description Summary: Director, Site Quality Operations is a leadership role responsible for leading all operational quality functions supporting the manufacture of transcatheter heart valves, delivery catheter systems, and associated components. This role ensures products are manufactured in compliance with global regulatory requirements while driving operational excellence, supplier performance, process capability, sterility assurance and compliance with JenaValve’s Quality Management System (QMS).

The Director partners closely with Manufacturing, Engineering, Supply Chain, Clinical, Regulatory Affairs, and R&D to ensure safe, effective, and compliant products are consistently delivered to patients worldwide. This position requires a proven leader capable of influencing strategic decision-making, leading process validations, transfers and manufacturing expansions, developing high-performing teams, sustaining long-term operational compliance.

Job Responsibilities:

Manufacturing Quality

• Lead all Quality Operations supporting the commercial manufacture of heart valves and delivery catheters systems.
• Develop and execute the operational quality strategy aligned with company objectives.
• Ensure appropriate implementation of process controls and quality plans.
• Oversee manufacturing quality metrics and indicators.
   

Receiving Inspection

• Lead Receiving Inspection organization.
• Ensure timely inspection and release of incoming materials.
• Develop risk-based inspection strategies.
• Implement inspection automation where appropriate.
• Ensure appropriate inspection methods are validated.
• Reduce incoming inspection cycle times while maintaining compliance.

Supplier Quality

• Develop supplier qualification and monitoring strategy.
• Oversee supplier audits, supplier CAPAs, the SCAR program, supplier performance scorecards, supplier risk management.
• Drive supplier process capability improvements.
• Support supplier transfers and dual-sourcing initiative.

Valve Manufacturing Quality

• Provide quality oversight for the manufacture of biological tissue valves.
• Ensure manufacturing processes maintain critical quality attributes.

Delivery Catheter Quality

• Provide quality leadership for the manufacture of catheter delivery systems.
• Ensure robust process validation and statistical process control for critical manufacturing processes.

Sterilization

• Own Quality oversight of sterilization programs and ensure compliance with: ISO 11135, ISO 11137, ISO 11737, ANSI/AAMI guidance as applicable.

Bioburden & Microbiology

• Lead Quality oversight of microbiological control systems including bioburden monitoring, environmental monitoring, cleanroom monitoring, water system monitoring, sterility testing, microbiological data, and investigation of excursions.

Process Validation

• Provide oversight of validation activities, including IQ/OQ/PQ, Process Performance Qualification (PPQ), cleaning validation, packaging validation, computer system validation supporting manufacturing, test method validation, revalidation strategy,
• Ensure lifecycle validation is maintained throughout commercial production.

Leadership

• Lead, mentor, and develop managers, engineers, inspectors, and quality professionals while building succession plans and talent pipelines.
• Build a high-performance quality culture focused on patient safety and operational excellence.
• Foster collaboration across Quality, Operations, Engineering, and Supply Chain.

Required Education and Experience:

• Bachelor's degree in Engineering, Life Sciences, or related technical discipline.
• 12+ years of medical device quality experience.
• 7+ years of leadership experience.
• Experience with transcatheter heart valves, structural heart devices, cardiovascular implants, or other Class III implantable devices preferred.
• Experience leading regulatory inspections and external audits preferred.

Skills and Abilities Required for This Job:

• Demonstrated experience supporting commercial manufacturing operations.
• Deep knowledge of FDA QMSR, ISO 13485, ISO 14971, EU MDR, MDSAP.
• Experience with supplier quality management.
• Experience with sterilization and microbiological controls.
• Strong understanding of process validation and manufacturing controls.

Physical Requirements:

• Ability to travel domestically and internationally up to 30%.