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 within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.

Benefits & Compensation

Medtronic offers a competitive Salary and flexible Benefits Package
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.

Salary ranges for U.S (excl. PR) locations (USD):$211,200.00 - $316,800.00

This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).

This position is eligible for an annual long-term incentive plan.

The base salary range is applicable across the United States, excluding Puerto Rico. Base pay is based on numerous factors and may vary by job-related knowledge, skills, experience, etc. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).

The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance , Health Savings Account , Healthcare Flexible Spending Account , Life insurance, Long-term disability leave , Dependent daycare spending account , Tuition assistance/reimbursement , and Simple Steps (global well-being program).

The following benefits and additional compensation are available to all regular employees: Incentive plans, 401(k) plan plus employer contribution and match , Short-term disability , Paid time off , Paid holidays , Employee Stock Purchase Plan , Employee Assistance Program , Non-qualified Retirement Plan Supplement (subject to IRS earning minimums) , and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).

Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico.

Further details are available at the link below:

Medtronic benefits and compensation plans

About Medtronic

We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people.
We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.

Learn more about our business, mission, and our commitment to diversity here.

It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.