Principal Quality System Specialist - Neurovascular - Irvine, CA (Onsite)

Medtronic • Irvine, CA

320d • $110,400 - $165,600

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. In this role as Principal Quality System Specialist, you will be responsible for multiple elements including but not limited to acting as a specialist within the CAPA process, creating, reviewing and providing guidance to change orders, and audit support activities for the Medtronic Neurovascular business.

Requirements

• Requires Bachelor's degree in Science or Engineering with minimum of 7 years of experience in Quality or regulated industry, OR Advance degree in Science or Engineering with minimum of 5 years of experience in Quality or regulated industry.
• Requires mastery of a specialty area and full knowledge of industry practices, typically obtained through advanced education combined with experience.
• May have broad knowledge of project management.
• Prior working knowledge of CAPA execution, creation and analysis of CAPA metrics.

Nice To Haves

• Experience working with Management Review, Change Control and Audit processes.
• Experience with TrackWise and Agile PLM software.
• Understanding of 21CFR 820, 806, 803, Part 11, Part 4; ANVISA, TGA, Health Canada, EU, China & Japan regulations; ISO 13485, MDSAP, etc.
• Knowledge of effective root cause investigation, corrective and preventive action planning, execution and verification of effectiveness techniques.
• Experience with quality tools and process improvement techniques.
• Influence management skills; ability to work constructively across all functions of the organization and build relationships as well as with external customers and regulators.
• Independent compliance decision maker (based on knowledge of regulations, available relevant information, alternatives, risk).
• Experience reviewing technical documentation.
• Strong written and verbal communication skills.
• Strong critical thinking and analytical skills.
• Lean Sigma certified or demonstrated problem solving experience.

Responsibilities

• Provides oversight for the development and maintenance of quality programs, systems, processes and procedures that ensure compliance with policies and that the performance and quality of services conform to established internal and external standards and guidelines.
• Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance.
• Works directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet regulations.
• Leads audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the audits.
• Prepares reports and/or necessary documentation (i.e., Corrective and Preventative Actions) and provides to applicable stakeholders, both internal and external.
• Co-ordinates legal requests in support of government investigations or litigations.
• Ensures the quality assurance programs and policies are maintained and modified regularly.
• Facilitates uniform standards worldwide and enables best practice sharing, thereby fostering the achievement of the company's mission globally.

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
• Education Level: Bachelor's degree