Principal Quality Systems Specialist

Medtronic • Santa Rosa, CA

351d • $124,000 - $186,000 • 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. The Structural Heart and Aortic integrated operating unit offers minimally-invasive approaches to restore proper structure and function of the heart and the aorta. We focus on the transcatheter replacement or repair of the four heart valves-aortic, pulmonic, mitral, tricuspid-and the placement of stent grafts to treat aneurysms and dissections of the body's largest artery, the aorta. In this exciting role as a Principal Quality Systems Compliance Specialist you will have responsibility for compliance to Quality System processes including External and Internal Audit processes to Medical Device regulations and requirements.

Requirements

• Requires a Bachelors Degree
• Minimum of 7 years of medical device quality, regulatory or engineering experience, or an advanced degree with a minimum of 5 years of medical device quality, regulatory or engineering experience.

Nice To Haves

• Experience working in medical device, pharmaceutical and/or a comparable regulated environment
• Experience working with Quality Systems procedures and requirements
• Experience working with audit findings, corrections, and corrective actions
• Experience working with external standards and reviewing technical documentation
• Experience with quality tools and process improvement techniques
• Knowledge of effective root cause investigation, corrective and preventive action planning and execution and verification of effectiveness techniques
• Influence management skills; ability to work constructively across all functions of the organization as well as external customers
• Ability to educate people on Quality Systems, Audit, and CAPA programs
• Project management skills
• Strong written and verbal communication skills
• Strong analytical and decision-making skills
• Understanding of FDA regulations (21 CFR 820, 210/211 as applicable and Part 11), ISO 13485, and Medtronic quality requirements.

Responsibilities

• Provides continuous and rigorous assessment of quality system, compliance, audit activities, processes, and documentation to assure compliance with Medtronic internal policies and quality system processes, FDA regulations, ISO 13485, Medical Device Requirements, and governmental regulations.
• Leads and assists in preparation for internal and external regulatory and notified body audits including FDA. Participates in internal and external audits and inspections in multiple audit support roles in the front and back room. Supports response owners with root cause, correction, corrective action, and effectiveness. Conducts internal audits and mock audits for SH&A entities and functions.
• Prepares Quality System compliance training materials and provides Quality System compliance training to entities and functions within the SH&A organization.
• Leads quality system projects. Participates in Quality System process activity across multiple sites including quality system projects and initiatives.
• Provides guidance, support and mentors quality process owners. Supports the development and implementation of Quality System procedures.
• Provide Quality System metrics and reporting on critical aspects regarding the health of the Quality System.
• Performs other related duties as assigned.

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

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