Director, Valve Manufacturing Quality & Operations

JenaValve Technology, Inc.; Irvine (CA); On-site; USD 180,000 - 240,000; Full time

Job summary

JenaValve Technology, Inc. in Irvine, CA, seeks a Director, Site Quality Operations to lead quality functions across valve manufacturing and delivery systems, ensuring products meet regulatory requirements and patient safety.

You will partner with Manufacturing, Engineering, Supply Chain, Regulatory Affairs, and R&D to drive process validation, supplier performance, and continuous improvement, while developing high-performing teams.

Qualifications

• 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.

Responsibilities

• Lead all Quality Operations supporting the commercial manufacture of heart valves and delivery catheter 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.
• Lead Receiving Inspection organization and drive supplier quality programs.
• Own Quality oversight of sterilization programs and ensure compliance with applicable standards.
• Provide quality leadership for catheter delivery systems manufacturing and process validation.

Skills

Medical device quality experience

Leadership experience

Regulatory knowledge (FDA QMSR, ISO 6

Cross-functional collaboration

Education

Bachelor's degree in Engineering, Life Sciences, or related technical discipline

Job description

JenaValve Technology, Inc. in Irvine, CA, seeks a Director, Site Quality Operations to lead quality functions across valve manufacturing and delivery systems, ensuring products meet regulatory requirements and patient safety.

You will partner with Manufacturing, Engineering, Supply Chain, Regulatory Affairs, and R&D to drive process validation, supplier performance, and continuous improvement, while developing high-performing teams.