Senior Quality Applications Specialist
MedtronicAbout 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
Act boldly. Compete to win. Move with speed and decisiveness. Foster belonging. Deliver results…the right way. That’s the Medtronic Mindset — our cultural norms. Our brand is rooted in action, not just words. The Medtronic Mindset defines the expectations of our culture. Every person here plays a role in bringing it to life. We recognize your extraordinary potential to ensure future generations live better, healthier lives.
At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We’re working a minimum of 4 days a week onsite as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary.
Responsibilities may include the following and other duties may be assigned:
Partner with change management process development resources and draft new and revised documents necessary to support users in their effective, efficient, and compliant usage of Product Lifecycle Management (PLM) capabilities and compliance with business process requirements
Partner with document owners at all levels (Enterprise, Shared, Local, etc.) to ensure alignment is maintained between documented processes
Be proficient in working within medical device Quality Management System change control requirements
Advise enterprise- and local-level stakeholders on potential impacts resulting from documents created and revised
Consult Product DNA experts on usage of the PLM system to create and manage change workflows, parts, documents, contexts, resources, etc.
Host stakeholder reviews and disposition feedback
Route, release, and effect changes in PLM to support release go-lives
Work with translations teams to clarify content as needed
Advise training teams as needed to inform training content creation and revision
Use PLM systems proficiently to help verify system behavior (e.g., step sequence, required fields, system validations, etc.)
Must Have: Minimum Requirements
To be considered for this role, please ensure the minimum requirements are evident on your resume.
Bachelor's degree with 4+ years of work experience in Quality or regulated industry OR Advanced degree with 2+ years of work experience in Quality or regulated industry.
Nice to Have (Preferred Qualifications)
Bachelor’s degree in relevant field required with a minimum of 7 years of Quality Management System, Document Writing, and/or Regulatory experience in medical device or regulated industry OR advance degree with a minimum of 5 years Quality Management System and/or Regulatory experience in medical device or regulated industry.
Ability to write clear, concise, and comprehensive instructions
Experience with Medtronic’s Enterprise Windchill configuration of PLM change workflows, parts, documents, contexts, resources, etc.
Ability to expertly navigate software
Experience developing document content (e.g., work instructions, job aids, technical guides) that promotes efficient and effective business processes, with emphasis on ease of use and understanding by a broad audience with varying expertise
Experience incorporating user feedback
Excellent organizational and time management skills
Effective verbal and written communication skills and the ability to tailor communication for different audiences
Good balance of high-level strategic and detailed, tactical thought processes
Demonstrated track record of successfully driving deliverables to completion under tight time constraints
Ability to strongly advocate for, and represent, DNA Implementation to a cross-f
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