Senior Quality Systems Specialist

Medtronic • Plymouth, MN

1d • $89,600 - $134,400 • Onsite

About The Position

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. 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. Join our collaborative team at our manufacturing site in Plymouth, MN to put our patients first through ensuring compliance in everything we do. In this role as a Senior Quality Systems Specialist, you will ensure compliance with Medtronic policies, FDA regulations, ISO 13485, and other requirements. You also will provide guidance and mentorship on CAPA processes and tools, such as root cause analysis, and participate in both internal and external audits and inspections. Additionally, you will support the Quality Management System by performing continuous improvement activities and ensuring that processes are compliant to regulations as well as meeting the needs of site Operations. 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 5 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.

Requirements

• 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
• For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.

Nice To Haves

• QMS experience, with knowledge of ISO 13485, EU MDR, and FDA CFR preferred
• Experience with CAPA and Root Cause Analysis tools
• Ability to set up and support internal and external audits, and coordinate responses and resolutions to findings
• Agile and Trackwise systems knowledge
• Strong capabilities with PowerPoint, Word, and Excel

Responsibilities

• Participate in the development and maintenance of quality programs, systems, processes and procedures that ensure compliance to established internal and external standards and guidelines.
• Provide expertise and guidance in interpreting internal policies and procedures, as well as external standards, regulations, and country requirements to ensure compliance.
• Assist in monitoring Corrective and Preventative Actions (CAPAs) for rigor and timeliness, as well as mentoring root-cause analysis sessions and change-impact assessments using a variety of problem-solving techniques.
• Lead audit and inspection preparation, resolution of audit and inspection findings, and liaises with auditing groups and inspectors through all stages of the audits.
• Prepares metrics and report-outs and provides to applicable stakeholders.
• Engage in the development of management presentations, including driving participants to provide timely metrics and escalations.
• Coordinate Enterprise-initiated changes with impacted departments to identify and make required changes to site documentation for compliance.
• Ensure the quality assurance programs and policies are maintained and modified per periodic review requirements or project needs.
• Work cross-functionally to provide guidance on the development and maintenance of quality plans to track quality-impacting projects.
• Manage projects, as assigned, for appropriate scoping, cross-functional resourcing, and timeliness, with consideration, escalation, and resolution for quality impacts

Benefits

• Health, Dental and vision insurance
• Health Savings Account
• Healthcare Flexible Spending Account
• Life insurance
• Long-term disability leave
• Dependent daycare spending account
• Tuition assistance/reimbursement
• Simple Steps (global well-being program)
• Incentive plans
• 401(k) plan plus employer contribution and match
• Short-term disability
• Paid time off
• Paid holidays
• Employee Stock Purchase Plan
• Employee Assistance Program
• Non-qualified Retirement Plan Supplement (subject to IRS earning minimums)
• Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)

What This Job Offers

• Job Type: Full-time
• Career Level: Senior