Medtronic is an Equal Opportunity/Affirmative Action Employer
The Director of Corporate Compliance will provide leadership and strategic vision to advance Medtronic’s Quality processes across the enterprise. In this role, the director will maximize effectiveness of the Compliance, Quality Audit, Global Quality System, and Data Analytics/Reporting function. Additional responsibilities will include the application of risk management strategy to the compliance and audit programs at Medtronic. As part of the role, the director will also lead the Medtronic Compliance Council and Quality System Architecture/Harmonization Council, which develop and implement quality strategies, and annual initiatives, within their scope. The role will require cross functional, cross business and global implementation strategies to influence the highest possible quality in our Global Medtronic brand. This position reports to the Vice President, Corporate Quality.
• Develop and implement strategy for a world-class, industry-leading Quality Compliance function ensuring continuous integration of emerging risk areas, and driving rigor into the process across the enterprise. Trend issues in global compliance related to Quality and identify improvement initiatives. Leverage strong relationships across global businesses, functions and regions to ensure full adoption of global standards.
• Effectively identify and communicate compliance risk to the organization and senior leadership leveraging external environment, data, metrics, audit reports, and audit results.
• Assemble the content and analyses for the Medtronic global quality management reviews to ensure senior leadership oversight of key compliance risks.
• Maintain an effective and compliant Global Quality System, including a corporate QS for the world headquarter site, and ensure appropriate escalation of risks through management review.
• Build and maintain strong partnerships with leaders in Quality, Legal Regulatory, Operations, Regulatory and R&D across Medtronic to assess risks and effectively influence risk management across the corporation. Identify appropriate escalation criteria for involving functional partners in risk decisions.
• Oversee the development and implementation of rigorous performance and quality indicators to measure and maximize current program effectiveness in quality strategic initiatives, audit, quality systems and compliance, including but not limited to risk assessment, stakeholder feedback, and trend analysis of both internal and external audit and quality performance indices.
• Provide leadership and manage team members including: recruiting, developing and retaining top/key education talent, coaching and performance management of staff.
• Maintain knowledge of technology trends and leverage where appropriate to add value to infrastructure.
• Maintain communication with internal and external customers to ensure effectiveness of Global Quality Compliance.
• Lead the Medtronic Compliance Council and Quality System Architecture/Harmonization Councils. Define the structure and related sub-councils needed to execute on the council and departmental strategies.
• Ensure successful IT infrastructure to support Corporate Compliance and council objectives.
• Prepare and manage budget to align resources to support business objectives.
• Effectively and efficiently report on key initiatives to senior leadership.
Bachelor’s degree in science or technology discipline (e.g., Engineering, Business, Quality or Life Sciences) with 10 + years of experience in quality functions including Quality Audit, Quality Systems, Pre market, Operations or Post market Quality
• Experience tracking international compliance metrics in a medical device organization
• Experience working in a regulated industry (Medical Device or Pharma)
• Product Development and/or project management experience in the medical device or pharmaceutical industry.
• Auditor Certification from recognized third party
• Demonstrated application of risk based approach to the auditing function.
• Advanced experience leading teams and driving strategic, enterprise wide change.
• Demonstrated high level of strategic thinking, customer focus risk assessment and judgment.
• Strong interpersonal and communication (both verbal and written) skills. Ability to facilitate teams and deliver presentations.
• Effective relationship management, ability to network, support and influence across organizational and functional boundaries.
• Proven success in coaching, developing and managing people; team-building.
• Aptitude for new technology
The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.