Quality Systems Manager, Senior

Medtronic   •  


Industry: Manufacturing


8 - 10 years

Posted 30 days ago

Careers That Change Lives

In this exciting role as a Senior Quality Systems Manager, you will have primary responsibility for managing the internal audit program, quality system governance, and leading improvement activities that improve efficiency, compliance, and reduce cycle time. The candidate will manage the quality system and compliance team.

The Restorative Therapies Group develops life-restoring therapies and healthcare solutions that span the care continuum; integrating technologies and applying clinical and economic evidence to increase patient access, improve efficiency of procedures and deliver successful patient outcomes.

PAIN THERAPIES offers solutions — from early interventional procedures to implantable surgical technologies — that treat chronic pain as well as pain from spinal fractures, cancer and severe spasticity.

A Day in the Life:

  • Coordinates and/or completes internal/external risk assessments and/or audits and compliance in accordance with regulatory standards, which may include US and/or international regulatory agencies / authorities.
  • Manages and oversees internal audit activities, which may include conducting and/or overseeing audits, investigations, and/or interviews; and preparing corresponding reports and documents.
  • Leads external audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspector through all stages of the audits
  • Co-ordinates legal requests in support of government investigations or litigations.
  • Ensures the quality assurance programs and policies are maintained and modified regularly.
  • Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal requirements
  • Provides oversight for the development and maintenance of quality programs, systems, processes and procedures and ensures compliance to established internal and external requirements.
  • Supports Quality System initiatives that improve efficiency, compliance, and reduce cycle time.
  • Prepares reports and/or necessary documentation (ex Corrective and Preventative Actions) and provides to applicable stakeholders, both internal and external.
  • Facilitates uniform standards worldwide and enables best practice sharing, thereby fostering the achievement of company's mission globally.

Must Have: Minimum Requirements

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

  • Bachelors degree in Engineering, Science, or Technical Discipline required.
  • Minimum of 7 years of quality systems experience with 5+ years of managerial experience
  • Advanced degree with a minimum of 5 years of quality systems experience with 5+ years of managerial experience

Nice to Have: Preferred Requirements

· Excellent communication skills (written and oral)

· Ability to co-ordinate cross functional activities

· Ability to initiate and lead process improvements

· Deep knowledge and understanding of Worldwide Medical Device Regulations and Standards

· Highly developed people management skills


Industry-leading Healthcare

Competitive Retirement and Stock Programs

Educational Resources and Financial Assistance

Family Care Leave

Matching Gift and Volunteer Grants

Opportunities to Network and Grow


Flexible Paid Time Off

Well-being Resources, Activities and Rewards

A “Thank-You” Culture

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. Let’s 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)