We anticipate the application window for this opening will close on - 8 May 2025

 

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.

A Day in the Life

Join us at Medtronic, where we are partnering across the industry to tackle systemic healthcare challenges with bold leadership. If you seek a challenging, energizing, and rewarding career that changes lives, we invite you to join our team. Become part of the next generation of life-changing medical technology, impacting patients worldwide.

As the Sr. Manufacturing Operations QA Director based in Irvine, you will serve as the Quality Site Leader for Manufacturing Operations in Irvine and Santa Ana, California. Reporting to the Vice President of Operations Quality for Americas West/Mexico Manufacturing Region, you will lead quality management strategies to ensure the highest level of product quality and compliance across two sites in Orange County, CA:

• Santa Ana – Surgical Valve and Transcatheter Valve

• Irvine – Stroke/Aneurysm and Embolization

Your role will be responsible for harmonizing standards and processes among these sites, driving synergies, and fostering a culture of quality excellence.

Key Responsibilities as the Sr. Manufacturing Operations QA Director are:

• Leadership & Quality Culture: Lead both manufacturing sites towards excellence in product quality and operational excellence, fostering a culture that prioritizes quality and puts patients first. Champion continuous improvement and quality excellence, embedding quality in every aspect of operations.

• Talent Development: Develop and implement comprehensive training programs to enhance team skills and capabilities. Mentor and coach Managers and Engineers, providing opportunities for professional growth and career advancement.

• Inspection Readiness: Ensure manufacturing operations are inspection-ready every day by maintaining rigorous quality standards and documentation practices. Implement robust quality control processes and regular inspections to ensure compliance with regulatory requirements.

• Strategic Partnership: Collaborate cross-functionally with colleagues in Global Operations & Supply Chain,  Strategy & Technology, Supplier Quality, Micro & Sterilization Assurance Regulatory Affairs, R&D, and others to drive Quality and Enterprise Operations strategies.

• Quality Management: Oversee the development and maintenance of quality programs, systems, processes, and procedures that ensure compliance with policies and standards. Provide expertise in interpreting policies and regulations to assure compliance.

• Audit Leadership: Lead audit and inspection preparation, resolving findings, and liaising with auditing groups and inspectors. Facilitate uniform standards worldwide and enable best practice sharing.

• Continuous Improvement: Create a culture of continuous learning across areas of responsibility, identifying root causes of quality issues and institutionalizing organizational learning.

Must Have: Minimum Requirements

To be considered for this role, please ensure the minimum requirements and your permanent address are evident on your resume.

• Bachelor’s degree required.

• Minimum of 15 years of relevant Manufacturing Quality / Engineering experience with 10+ years of managerial experience, or an advanced degree with a minimum of 13 years of relevant Manufacturing Quality / Engineering experience with 10+ years of managerial experience.

Nice to Have

• Experience in Medical, Pharmaceutical or highly regulated product industry.

• DMAIC Lean / Six Sigma Certification and demonstrated experience leading DMAIC Projects.

• Demonstrated experience leading Kaizen Events and multiple Quality-related functions.

• Experience with tissue products.

• Strong leadership, change management, and transformation skills.

• Excellent communication, interpersonal, and talent management skills.

Physical Job Requirements

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. 

The physical demands described wit