Quality Systems Manager - Plymouth, MN
About The Position
The Quality Systems Manager provides leadership for the Quality Management System (QMS) at Medtronic's Nathan Lane manufacturing site in Plymouth, Minnesota. Supporting the production of life-changing medical technologies within the Peripheral Vascular Health portfolio, this site is a high-volume, highly regulated manufacturing operation focused on delivering safe, effective, and reliable products to patients around the world. In this role, you will partner closely with Operations, Quality, Manufacturing Engineering, Supply Chain, and Regulatory partners to ensure quality systems remain compliant, effective, and aligned with business objectives. As a key member of the site quality organization, the Quality Systems Manager will lead continuous improvement initiatives across core quality system processes, including compliance, audits, CAPA, document control, training, and management review activities. This leader will drive a culture of quality and operational excellence, ensuring regulatory requirements are met while enabling the business to scale, innovate, and continuously improve. The role requires strong cross-functional collaboration, sound decision-making, and the ability to influence stakeholders at all levels while advancing Medtronic's Mission to alleviate pain, restore health, and extend life. 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 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 a minimum of 5 years relevant experience, or advanced degree with a minimum of 3 years prior relevant experience
Nice To Haves
- Bachelor's degree in Engineering , Quality, Life Sciences, or a related technical field.
- Experience supporting Quality Management System (QMS) processes, including CAPA, nonconformance, change control, document control, training, or management review.
- Experience supporting FDA inspections, ISO 13485 audits, MDSAP audits, customer audits, or internal quality audits.
- Experience interpreting and applying FDA Quality System Regulation, ISO 13485, MDSAP, or other regulated quality system requirements.
- Experience supporting quality systems within the medical device, pharmaceutical, biotechnology, or other regulated industries.
- Experience partnering with Manufacturing, Operations, Engineering, Regulatory Affairs, or Supply Chain functions.
- Experience developing, monitoring , or reporting quality system metrics.
- Experience supporting quality systems in a manufacturing environment.
- Experience leading quality, compliance, audit, or continuous improvement projects.
- ASQ certification such as Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), Certified Manager of Quality/Organizational Excellence (CMQ/OE), or equivalent.
- 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.
Responsibilities
- 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.
- 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.
- Prepares reports and/or necessary documentation (ex Corrective and Preventative Actions) and provides to applicable stakeholders, both internal and external.
- 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.
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)
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What This Job Offers
Job Type
Full-time
Career Level
Manager
