Senior Principal Quality Systems Specialist - NM/PH - Fridley, MN (Onsite)

    • Medtronic
  • Fridley, MN
  • Posted 24 days ago | Updated 1 day ago

Overview

On Site
Full Time

Skills

Healthcare information technology
Software development
Leadership
Regulatory Compliance
Process analysis
Inspection
Auditing
Legal
Quality assurance
Policies
Documentation
Science
Quality management
FDA
ISO 13485
Medical devices
Process improvement
Organizational skills
Time management
Multitasking
SAP BASIS
Management
Motivation
Communication
Presentations
Recovery
Collaboration
Health care
ADA

Job Details

Careers That Change Lives

In this exciting role as a Senior Principal Quality Systems Specialist, you will have responsibility for managing assigned projects and working with stakeholders to achieve desired results within the Quality System.

Join a diverse team of innovators who bring their worldview, their unique backgrounds, and their individual life experiences to work every day. It's no accident - we work hard to cultivate a workforce that reflects our patients and partners. We believe it's the only way to drive healthcare forward and remain a global leader in medical technology and solutions.

To learn more about Inclusion & Diversity at Medtronic Click Here

This position is based in Fridley, MN supporting the Neuromodulation and Pelvic Health Operating Units.

Neuromodulation products provide therapy for a variety of conditions including Chronic Pain, Cancer Pain, Severe Spasticity, Epilepsy, Dystonia, Essential Tremor, and Parkinson's Disease. Products include implantable and external neurostimulators, implantable infusion pumps, and associated device recharge and programming instruments.

Pelvic Health therapies treat patients suffering from overactive bladder, non-obstructive urinary retention, and fecal incontinence with our sacral neuromodulation (SNM) systems InterStim X and InterStim Micro; and our percutaneous tibial neuromodulation (PTNM) system NURO .

Location: Fridley, MN

A Day in the Life

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

  • Provides oversight for the development and maintenance of quality programs, systems, processes, and procedures that ensure compliance with policies and that the performance and quality of services conform to established internal and external standards and guidelines
  • Partners with site management to lead quality initiatives that develop and maintain a higher performing, scalable, and compliant Quality System
  • Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance.
  • Works directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet regulations.
  • Leads audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors 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.
  • 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

  • Bachelor's degree in Science, Engineering or related field required with a minimum of 10 years of Quality Management Systems and/or medical device experience
  • OR advance degree in Science, Engineering, or related field with a minimum of 8 years of Quality Management Systems and/or medical device experience

Nice to Have (Preferred Qualifications)

  • Strong understanding of global regulatory requirements for medical devices, including FDA regulations (e.g., 21CFR Part 820), ISO 13485, Medical Device Directive, and European Medical Device Regulation.
  • Experience defining, driving, and implementing process improvement and functional excellence efforts.
  • Strong organizational skills and time management skills
  • Ability to multitask, support multiple projects, function on a global basis, prioritize, conduct team meetings, and meet project deadlines.
  • Proven experience in achieving results through influence management and motivating teams.
  • Good communication (oral and written), presentation and interpersonal skills.

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).
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.