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Principal Clinical Quality Specialist

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Clinical
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19000HAZ Requisition #
Thanks for your interest in the Principal Clinical Quality Specialist position. Unfortunately this position has been closed but you can search our 422 open jobs by clicking here.

Must Have: Minimum Requirements

To be considered for this role, the minimum requirements must be evident on your resume. 

  • Bachelor’s degree with a minimum of 7 years of experience supporting clinical research/quality and/or audits/compliance within the healthcare industry or advanced degree with a minimum of 5 years of experience supporting clinical research/quality and/or audits/compliance within the healthcare industry 
 

Nice to Have (Preferred Qualifications):

  • Proficient knowledge in FDA and international regulations and/or experience in Quality Systems regulations.
  • Clinical research / Clinical quality and/or audit experience at Medtronic or within the medical device industry.
  • Proficient knowledge in and experience with FDA and international regulations (e.g., 21 CFR Parts 812, 11, 50, 54, 56, 803, 806, 820, 312, ISO 13485, ISO 14155), the European Medical Device Regulations (EUMDR) and experience in Quality System regulations (21 CFR Part 820).
  • FDA inspection support, external audit, and internal audit facilitation; applied knowledge of FDA BIMO inspection manuals, and experience supporting Medical Device Single Audit Program (MDSAP)audits.
  • Experience in Good Clinical Practice (GCP) and/or regulatory compliance guidelines for clinical trials. Ability to incorporate and adhere to good clinical practices and regulatory standards.
  • Proficiency in MS Office applications: Excel, PowerPoint and Word, Project (or similar scheduling software), project management techniques and tools; and Medtronic web-based applications such as Agile, RAD, Trackwise, CTMS.
  • Project/program management experience.
  • Regulatory submission review and support

Additional information to be considered:

  • High attention to detail and accuracy
  • Self initiator and ability to manage multiple tasks
  • Strong interpersonal skills; ability to work with teams and management to resolve compliance concerns,

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 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)

Domestic and International travel up to 20%.

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Change Begins With You

We look for bold ideas and fresh insights - that's what drives innovation. Come drive the future of healthcare with us.

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Join us in our challenge to make global healthcare more affordable and accessible. Your insight and oversight will help us create solutions that change the world.

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The mission to improve access to healthcare globally is something we are all very proud to work hard toward achieving. Great people, fun atmosphere, big city salaries. The CEO is fantastic - he is a very clear communicator of the mission and is truly dedicating his life to achieving it.
Smart and committed coworkers. Mission driven. Good benefits. Good long term career opportunities. Company is large enough that you can always find interesting projects to work on.
Knowing that everyday your work helps to save lives makes it great place to work. Training on lean practices, quality and other. Excellent peers.

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