Senior Quality Systems Specialist

Medtronic • Grand Rapids, MI

2d • 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. 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. A Senior Quality Management System Specialist will be responsible for overseeing and managing the QMS, driving continual improvements and updates. Accountable for leading Quality Management Reviews, Trend Reviews, and the Change Order Review Board, as well as implementing updates in alignment with Quality Management Transformation Packages. The Medtronic Grand Rapids Manufacturing site is a key facility focused on the production of high-quality medical devices and components related to Cardiac and Vascular Group. The site is known for its commitment to operational excellence, quality assurance, and continuous improvement. It plays an important role in advancing Medtronic’s mission to alleviate pain, restore health, and extend life. This role is 100% onsite at our Grand Rapids, MI manufacturing facility.

Requirements

• Requires a bachelor’s degree and minimum of 4 years of work experience in quality or regulated industry OR advanced degree with a minimum of 2 years of work experience in quality or regulated industry

Nice To Haves

• Experience with CAPA, QMS, audits and regulations (such as ISO 13485:2016)
• Agile, Trackwise system knowledge
• Experience with SAP
• Experience with supplier controls and incoming acceptance criteria
• Certified Quality Auditor (CQA) certification strongly preferred

Responsibilities

• Provide 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.
• Provide expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance.
• Work directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet regulations.
• Lead audit and inspection preparation, resolution of audit and inspection findings and liaise with auditing groups and inspectors through all stages of the audits.
• Prepare reports and/or necessary documentation (ex Corrective and Preventative Actions) and provide to applicable stakeholders, both internal and external.
• Co-ordinate legal requests in support of government investigations or litigations.
• Ensure the quality assurance programs and policies are maintained and modified regularly.
• Facilitate uniform standards worldwide and enables best practice sharing, thereby fostering the achievement of company's mission globally.
• Responsibilities may include the following and other duties may be assigned.

Benefits

• Medtronic offers a competitive Salary and flexible Benefits Package
• A commitment to our employees lives at the core of our values.
• We recognize their contributions.
• They share in the success they help to create.
• We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
• 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, and 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), and 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