Principal Quality Systems Specialist

Medtronic•Miami Lakes, FL

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 Provides regional quality oversight to ensure facilities programs, systems, and processes comply with internal policies and regulatory requirements Serves as a quality subject matter expert supporting audit readiness, CAPA management, training compliance, quality metrics, and standardized best practices across manufacturing and distribution center facilities. 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.

Requirements

Bachelor’s degree and 7+ years of experience in Quality Systems OR advanced degree and 5+ years of experience
3+ years of experience in quality assurance, regulatory compliance, or quality systems
Experience supporting audits, inspections, and CAPA management
Working knowledge of quality systems, documentation, and training compliance
Strong analytical, communication, and cross-functional collaboration skills
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

Experience supporting audits, inspections, and CAPA management
Working knowledge of quality systems, documentation, and training compliance
Strong analytical, communication, and cross-functional collaboration skills
Experience in regulated environments such as medical devices or life sciences
Experience with electronic quality systems such as TrackWise
Experience supporting multi-site or regional operations
Familiarity with facilities equipment validation and quality metrics

Responsibilities

Maintain audit tracker data and analyze dashboards to identify trends, risks, and improvement opportunities
Partner with regional Facilities leaders on audit performance and readiness
Support sites with audit and inspection preparation including onsite support for complex audits
Train Facilities Managers on audit preparation, conduct, and regulatory expectations
Act as subject matter expert for audit findings and CAPA management including TrackWise support
Lead resolution and reporting of audit findings, CAPA status, and key quality metrics
Review and standardize facilities-related quality documents and support document owners
Serve as subject matter expert for facilities quality systems and related tools
Manage training compliance dashboards and support training matrix administration
Identify training compliance gaps and drive closure plans
Serve as liaison between Facilities, Engineering, and site quality systems for equipment validation activities
Promote standardized quality practices and continuous improvement across sites

Benefits

Medtronic offers a competitive Salary and flexible Benefits Package
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)