Senior Quality Systems Specialist

Medtronic • Jacksonville, FL

4d • 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. 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.

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, 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: Mid Level
• Number of Employees: 5,001-10,000 employees