Quality Engineering Director

Quality Engineering DirectorLocation:Memphis, Tennessee, United StatesRequisition #:220000RLPost Date:10 hours agoCareers That Change LivesWe are entering an era of transformation in spine and cranial surgery and one that is driven by growth in technology, data, and artificial intelligence (AI). This role in the Quality function will focus on the newly created intelligent Data Solutions (iDS) business, within the CST Operating Unit (OU). The role will build upon the foundation of the recent Medicrea acquisition and expand our global reach across key areas of data and AI solutions, focusing on the full lifecycle of products. Bring your leadership skills and passion to lead within this transformative new business!A Day in the LifeResponsibilities may include the following and other duties may be assigned:Plans, directs, and implements quality aspects of new medical devices or software systems, including software as a medical device (SaMD), within the business.

Ensures that approaches are innovative, industry leading, and meeting the needs of customers and OU strategies.

May develop, evaluate, implement and maintain technical quality assurance and control systems, reliability systems or processes, and standards pertaining to business products.

Oversees the investigation and evaluation of enhancements and changes to existing technologies.

Implements and monitors processes verifying compliance to regulations and standards in use throughout the QMS.

Creates a culture of continuous learning across areas of responsibility.

Organizes the coordination and effectiveness of quality activities across other enterprise structures to ensure timely delivery and desirable service levels.

Selects, develops, and evaluates personnel to ensure the efficient operation of the function within the business.

Builds a high-performance team and works with internal and external stakeholders to deliver results to quality strategy.

Completes acquisition integration and remediation plans, and builds plans to grow process maturity.

Communicates status updates regularly to business General Manager, business leadership, and other senior leaders.

Ensures the business annual operating plan and strategy supports Medtronics and CSTs overall strategy and goals.

LOCATION: A REMOTE LOCATION WILL BE CONSIDEREDMust Have: Minimum RequirementsBachelors 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

Nice to Have: Preferred RequirementsPromoting and implementing a culture of quality spanning across a business

Relevant management experience leading site(s) or function

Experience owning a financial cost center, program financials, and/or leading efforts for responsibilities within an Annual Operating Plan (AOP)

Strong organizational and business acumen with the ability to communicate effectively to non-technical audiences

Experiencebuildingmeaningful relationshipswith business partners to ensure business value and results are delivered accordingly

Ability tolead teamsconsisting ofboth direct and indirectemployees, through onsite and remote styles of leadership

Predictive analytics and/or software engineering experience; Awareness and/or experience of regulatory oversight of SaMD

Experience / knowledge of regulator strategic initiatives for advancement in regulatory science, including industry advocacy groups

Experience with design controls within product development process. Experience with IEC 62304 or other relevant regulated software development standards or requirements

About MedtronicTogether, 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 RequirementsThe 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.