The Director, Quality Systems and Operations serves as the owner of quality system development and deployment for St. Jude Neuromodulation’s (NMD) worldwide operations. The scope of these responsibilities includes direction of quality function operations at the Division’s New Jersey, Portland and Plano sites, as well as the development, implementation and on-going improvement of quality systems across the enterprise.
The Director must successfully support and deploy the quality systems vision and strategy to the Division, and must translate the vision into tangible organizational goals. The Director identifies and recruits staff and resources to support quality system projects, and is responsible for managing the daily activities of a Division-level, professional staff, and multi-site quality operations through individual site Quality Managers.
The Director must work with multiple NMD functions (RA, Ops, R/D, all levels up to and including Division President) and Corporate Quality staff (VPs, Directors) in the development of the Quality System and the alignment of Corporate and NMD policies.
This position is also responsible for the preparation and presentation of the Division’s Management Review, and for the development, analysis and improvement of the Quality System’s Key Performance Indicators (KPI). The Director, Quality Systems and Operations will be the project owner for the Division’s Quality Systems Improvement Plan until completion and endorsement of the improvements through future third-party audits and inspections.
Major, On-Going Responsibilities:
• Directs short and long term goals surrounding the quality system and develops the long range plan for the quality system;
• Directs quality operations through site Quality Managers and ensures effective deployment of the quality system. Must drive division to achieve positive outcomes with regard to closing compliance gaps, certifying to new standards and maintaining current licenses/certifications.
• Develop staff capabilities in technical areas and key technologies associated with the Company’s Continuous Improvement program (e.g., Six Sigma).
• Serves as a primary contact to represent NMD’s quality system during FDA, ISO and other regulatory body inspections.
• Responsible for the development and deployment of the NMD Quality System across sites in accordance with applicable Quality System Regulations and ISO standards world-wide; must continue to be well informed and review changes before changes are enforced.
• Serves as an internal consultant relative to identification, analysis and remediation of compliance issues associated with the Quality System.
• Responsible for reporting to top management on the performance of the quality management system and any need for improvement and ensuring the promotion of awareness of regulatory and customer requirements throughout the organization.
• Develop and implement operating plans and budgets for areas of responsibility.
• Engage in strategic planning and leadership activities as a member of the Vice President, Quality Assurance’s staff.
• Responsible for compliance training content development and deployment.
Experience and Training:
• Bachelors degree in Engineering or Science required, Masters in related field or MBA preferred
• 10 to 20 years quality assurance background is required
• Experience with medical device or regulated industry is required
• Experience with quality system development and design is required
• Experience with risk management and ISO 14971 familiarity required
• Must have minimum of 5 years management experience
Demonstrated leadership skills, acting as a change agent in the implementation of Quality Systems. Comfortable and effective working across organizational lines. Able to articulate decisions in a logical fashion and present recommendations and proposals for action to all levels of management. Applied compliance experience and judgment must be sound, and should include interfacing with the Food and Drug Administration. Percent of travel: 20-40%