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Director of Quality - Site Lead

Irvine, CA 92604
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Director of Quality - Site Lead


Irvine, California, United States

Requisition #:


Post Date:

Mar 02, 2022

**Careers that Change Lives**

The Director of Quality - Site Leadhas responsibility for leading operations quality and the deployment of quality systems at the Neurovascular plant in Toledo Irvine, CA.

This position acts as liaison with OUs, and other sister manufacturing facilities within the Platform to drive quality management strategies and activities resulting in the highest level of product quality and compliance. Emphasis will be on first time quality and continuous improvement of processes and systems and the execution of site quality strategies through direct accountability and influence within the operations organization. This position provides leadership and resources to ensure compliance with all elements of the quality management system throughout the organization and ensuring quality system performance is measured and routinely reported/ escalated to executive management

**A Day in the Life**

Responsibilities may include the following and other duties may be assigned.

+ Develops and deploys Quality and Compliance strategies that are aligned with Medtronics strategy across areas of responsibility.

+ Reviews, directs and manages manufacturing QA strategies, organization, and execution for results. Ensures that approaches are innovative, industry leading, and meeting the needs of customers and OU business strategies.

+ Collaborates with the operations teams as well as other internal and external partners to ensure the strategy is executed to achieve significant and measurable results.

+ Develops and maintains appropriate communications between OUs to deliver on Medtronics overall quality and operations needs worldwide, collaborating as appropriate to ensure synergies with and between organizations to leverage a harmonized approach whenever possible.

+ Proactively manages quality assurance and compliance activities in order to produce the highest quality products and prevent defects.

+ Creates a culture of continuous learning across areas of responsibilities where root causes on quality issues are identified and organizational learning is institutionalized.

+ Ensures effective processes are established within the organization to monitor quality and compliance execution. Implement proactive and preventive strategies for the resolution of quality and compliance opportunities.

+ Assures the processes used in the manufacturing of products are properly developed, characterized, qualified, and validated to assure the highest possible quality and to ensure an uninterrupted supply of quality product to meet the needs of our customers.

+ Assures that manufacturing quality and performance data are comprehensively measured, trended, reported, and acted on in a timely manner to ensure compliance and support continuous improvement. Ensures constant vigilance in line rejects, manufacturing related field returns of those products and changes to manufacturing process to assure the highest possible quality.

+ Creates a world class Quality organization ensuring top talent is hired, developed, and retained.

+ Lead the strategic planning efforts for area of responsibilities in the Annual Operation Plan (AOP).

**Must Have: Minimum Requirements**

+ Bachelors degree

+ Minimum of 10 years of relevant experience with 7+ years of managerial experience, or advanced degree with a minimum of 8 years of relevant experience with 7+ years of managerial experience

+ Requires broad management and leadership knowledge to lead multiple job areas, and detailed functional and operational expertise

+ Working knowledge of Global Quality Systems regulations, and ISO 13485

**Nice to Have: Preferred Requirements**

+ Experience in Medical, Pharma or high reliability product industry

+ Experience in multiple Quality related functions

+ Highly results oriented and focused on business priorities

+ Strong leadership and influencing skills to drive results in a highly matrixed organization

+ Strong Business and Quality perspective

+ Strong change management and transformation skills

+ Strong understanding of Process Validation and statistical methods

+ Excellent Communication/Presentation Skills

+ Excellent Interpersonal and Talent Management skills

+ Supplier Controls process knowledge experience

**About Medtronic**

Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.

We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Lets work together to address universal healthcare needs and improve patients lives. Help us shape the future.

Physical Job Requirements

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. (ADA-United States of America)
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.


Posted: 2022-03-08 Expires: 2022-06-13
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Director of Quality - Site Lead

Irvine, CA 92604

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