Quality System Senior Specialist

Medtronic • Santa Clara, CA

75d • $89,600 - $134,400 • Hybrid

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. Medtronic seeks a Senior Quality Systems Specialist to develop and maintain quality programs for medical devices. The role ensures compliance with regulatory standards and supports quality improvement initiatives. This hybrid position is based in Yokneam, Israel/Santa Clara, California/ Lafayette, Colorado facilities. The role requires occasional travel and involves independent work to maintain quality standards across global operations.

Requirements

• Bachelor's degree in Engineering, Life Sciences, or related field with minimum 4 years of quality systems experience in medical device industry
• Strong knowledge of medical device regulations including FDA Quality System Regulation (QSR), ISO 13485, and Good Manufacturing Practices (GMP)
• Proven experience with audit management, CAPA processes, and Management review preparation
• Demonstrated ability to interpret complex regulatory requirements and translate them into actionable quality procedures
• Excellent analytical and problem-solving skills with experience in process improvement methodologies
• Strong communication abilities to interact effectively with senior management, regulatory agencies, and cross-functional teams

Responsibilities

• Provide oversight for development and maintenance of quality management systems, ensuring full compliance with FDA, ISO 13485, and other regulatory requirements
• Lead audit and inspection preparation activities, coordinate with regulatory bodies, and manage resolution of findings through comprehensive Corrective and Preventive Actions (CAPA)
• Conduct process analysis and risk assessments to identify improvement opportunities and ensure adherence to quality standards across manufacturing and design operations
• Collaborate with cross-functional teams to interpret regulatory requirements and implement quality policies that support our endoscopy and surgical device portfolios
• Prepare detailed quality reports and documentation for internal stakeholders and external regulatory agencies
• Facilitate global quality standards implementation and best practice sharing across international sites

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)

What This Job Offers

• Career Level: Senior
• Industry: Professional, Scientific, and Technical Services
• Education Level: Bachelor's degree
• Number of Employees: 5,001-10,000 employees