Senior Quality Systems Specialist

Medtronic • Jacksonville, 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 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.

Requirements

• Requires a Baccalaureate degree
• Minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.

Nice To Haves

• Strong understanding of Quality and Regulatory system standards such as ISO 13485 and ISO 14971
• Certified Quality Auditor (CQA), Certified Quality Engineer (CQE), or similar certification
• Thinks creatively, embraces new approaches, and maintains strong attention to detail.
• Demonstrates curiosity and a drive for continuous improvement.
• Proficiency with data analysis and visualization tools (MS Excel, Power BI, etc.)
• Strong analytical and problem-solving skills.
• Effective verbal and written communication skills.
• Experience with ERP systems (e.g. SAP)

Responsibilities

• Contributes to the development and maintenance of Quality programs, systems, processes, and procedures that ensure compliance with global policies, local regulations and practices.
• Supports monitoring and evaluation of process performance and quality to ensure conformance with internal and external standards.
• Provides guidance in interpreting policies, procedures, and external regulations to ensure compliance.
• Partners with cross-functional teams to identify and resolve compliance gaps and Quality issues.
• Supports audit and inspection preparation, execution, and resolution of findings.
• Supports Operating Unit and Enterprise change control processes.
• Supports the Field Corrective Action and Product Hold programs.
• Supports monitoring of key performance indicators and contributes to identifying improvement opportunities.
• Prepares QMS reports and provides necessary information to applicable internal and external stakeholders.
• Contributes to training and awareness initiatives that foster Quality culture and compliance.

Benefits

• Medtronic offers a competitive Salary and flexible Benefits Package
• 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
• 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).
• Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees