Senior Quality Systems Specialist

Medtronic • Santa Ana, CA

13h • 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. 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 onsite 4 days a week as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary. In this role as a Senior Quality Systems Specialist, you will provide oversight for the development and maintenance of quality programs, systems, processes, and procedures to ensure compliance with internal policies and external regulatory standards. You will serve as a key liaison during audits and inspections, lead audit readiness activities, and support ongoing Quality Management System (QMS) improvements. You will support all internal and external audits, including FDA inspections, Notified Body audits, and other regulatory inspections, ensuring a high state of inspection readiness and effective execution. As a Quality Systems leader, your day is dynamic and impactful, encompassing:

Requirements

• Bachelor’s Degree with a minimum of 4 years of relevant experience, or an advanced degree with at least 2 years of relevant experience.
• Unrestricted U.S. work authorization at the time of hire and for the duration of employment (for roles below Principal level).

Nice To Haves

• 5+ years of experience with FDA 21 CFR Part 820 and ISO 13485
• Lean Six Sigma certification
• Lead Auditor certification
• Familiarity with Medical Device Single Audit Program (MDSAP)
• Experience with TrackWise (Sparta)
• Experience with PLM systems such as Agile or Windchill

Responsibilities

• Oversee the development and maintenance of quality programs, systems, processes, and procedures to ensure compliance.
• Interpret and apply internal policies, regulatory, and governmental requirements to maintain compliance.
• Collaborate with operating entities to perform process analysis and ensure adherence to regulations.
• Lead and support all audit and inspection activities, including FDA inspections, Notified Body audits, and internal audits; manage audit preparation, execution, and resolution of findings.
• Serve as primary liaison with auditors and inspectors throughout all audit stages.
• Prepare reports and required documentation (e.g., CAPAs) for internal and external stakeholders.
• Coordinate legal requests related to government investigations or litigation.
• Ensure quality assurance programs and policies are maintained and updated.
• Promote global standardization and facilitate best practice sharing.
• Provide interpretation of regulatory requirements (e.g., FDA 21 CFR 820, ISO 13485) and strengthen QMS governance through harmonization across sites and business units.
• Lead coordination of all internal and external audits and inspections.
• Drive inspection readiness through structured preparation, risk assessment, and cross-functional alignment.
• Ensure effective communication, strategy, and execution during audits.
• Manage the Operations Quality Walk program by leading cross-functional teams in routine floor assessments against established criteria.
• Drive accountability, identify gaps, and ensure timely follow-up and continuous improvement actions.
• Manage SAP QM Local Data Administrator (LDA) activities, including support for material master data, inspection setup, and quality-related system configurations to ensure data integrity and compliance.
• Apply structured methodologies such as Lean, Six Sigma, and root cause analysis to resolve complex quality issues and improve processes.
• Lead projects, influence stakeholders, and provide mentorship and guidance to team members and cross-functional partners.
• Support Quality Management Review (QMR) activities by ensuring accurate data inputs, preparing reports, and facilitating discussions to drive compliance and continuous improvement at the leadership level.

Benefits

• Competitive Salary
• 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
• 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