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Senior Quality Systems Director

Medtronic
United Statesfull_timeVerifiedPosted 20 Aug 2024
💰 $316,800/yr

About the role

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

CAREERS THAT CHANGE LIVES:

In this exciting role, a day in the life as a senior leader in medical device quality systems can be quite varied and dynamic. You will be responsible for developing, implementing, and maintaining robust quality management systems in the Cranial and Spinal Technologies Operating Unit to ensure compliance with regulatory requirements and industry standards. This position will play a key role in driving a culture of quality excellence and continuous improvement throughout the organization. You will manage a team of professionals and will be accountable for mentoring, developing, and coaching them on meeting/exceeding performance expectations and defined objectives, and providing leadership to ensure the prioritization of strategic and department level initiatives.

A Day In the Life 

Responsibilities will include but are not limited to:

  • Define quality objectives and set priorities for quality improvement initiatives, developing strategies to enhance compliance with regulatory requirements, evaluating new technologies or processes to streamline quality systems. 

  • Define performance goals and targets; conduct hiring, performance reviews, and 1:1s to guide performance management and employee development efforts and manage toward departmental goals.

  • Provide expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance.

  • Work directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet regulations.

  • Lead audit and inspection preparation, resolution of audit and inspection findings and liaise with auditing groups and inspectors through all stages of the audits.

  • Prepare reports and/or necessary documentation (e.g., Corrective and Preventative Actions) and provide to applicable stakeholders, both internal and external.

  • Facilitate uniform standards worldwide and enable best practice sharing, thereby fostering the achievement of company's mission globally.

  • Stay informed about emerging trends, best practices, and regulatory changes in the medical device industry, and proactively identify opportunities for process improvements and risk mitigation.

  • Frequently communicates with higher level business unit, operating unit and portfolio leadership. Leads briefings and meetings with internal and external contacts.

  • Drives fiscal accountability to cost center AOP.

  • Travel: approximately 25%

Must Have: Minimum Requirements

To be considered for this role, please ensure the minimum requirements are evident in your applicant profile and on your resume.

  • Requires advanced management and leadership knowledge to lead cross-department project teams or manage across multiple functions.

  • Typically has achieved mastery within a specific technical or broad expertise across multiple related disciplines.

  • Requires a Baccalaureate degree (or for degrees earned outside of the United States, a degree which satisfies the requirements of 8 C.F.R. § 214.2(h)( 4)(iii)(A) and minimum of 15 years of relevant experience with 10+ years of managerial experience, or advanced degree with a minimum 13 years prior relevant experience, minimum of 10 years of managerial experience.

  • 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, recruiter or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)

  • For employees working in Quebec, Canada only: Basic knowl

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Company

Medtronic

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