Quality Systems Specialist

Medtronic Inc. Arden Hills , MN 55112

Posted 6 months ago

Careers that Change Lives

Your dedication is important to our customers and, most importantly, to their patients.

Medtronic is currently seeking a Quality Systems Specialist.

This position will be primarily responsible for supporting the development, documentation, maintenance and improvement of the site Quality Management System. This position will work closely with Quality Systems leadership (Process Area Leads) and Subject Matter Experts (Process Owners) to ensure the Quality System and processes are efficient, and compliant to internal and external requirements.

Do meaningful work, make a difference, and improve lives starting with your own.

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.

A Day in the Life

  • Support the development of Quality System policies, procedures, tools, systems and training programs.

  • Supports Quality System initiatives that improve efficiency, compliance, and reduce cycle time.

  • Provide consulting for implementation of Neuromodulation Quality System processes and Medtronic Policies.

  • Collaborate with Subject Matter Experts to develop clear objectives for the design of education packages that are complete and effective. Ensures high quality content and design for comprehension and retention.

  • Support the Medtronic Quality System Architecture, ensuring integration between processes.

  • Support CAPAs, non-conformance and audit observations

  • Supports external and internal audits and will frequently be called upon to provide backroom audit support.

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 standards and agency guidelines.

  • Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and agency guidelines to assure compliance.

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

  • 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.

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

Must Have: Minimum Requirements

  • Bachelor's Degree and 2+ years of experience OR Master's Degree and 0+ years of experience

Nice to Have (Preferred Qualifications):

  • Knowledge of FDA and international Quality System requirements

  • Strong analytical skills

  • Self-motivated and proactive team member

  • Excellent communication and presentation skills

  • Ability to effectively manage multiple projects and priorities and is flexible with priorities and responsibilities.

  • Results-oriented and decisive

  • Strong 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 above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.

The physical demands described within the Day in the Life 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.


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Quality Systems Specialist

Medtronic Inc.