Thursday, July 08, 2010
Director Quality Engineering - St Jude Medical - Neuromodulation (Plano, TX)
The Director, Quality Engineering directs operations for a broad range of Quality Engineering disciplines, including Electrical/Mechanical, Software, Biocompatibility, Sterility Assurance, Supplier Quality and Reliability Engineering. The Director manages an organization consisting of approximately 25-30 Managers, Engineers and Technicians.
The Director, Quality Engineering works cross-functionally with partner organizations to establish and carry out priorities and resource plans for new product development projects, supplier management initiatives, risk management activities, and problem handling and resolution actions.
Major, On-Going Responsibilities:
• Develop and implement systems and processes to manage risks throughout the product life-cycle.
• Establish priorities and set direction for Quality Engineering Managers and larger organization.
• Develop and implement operating plans and budgets for areas of responsibility.
• Engage in strategic planning/leadership activities as a member of the Vice President, QA’s staff.
• Develop staff capabilities associated with the Company’s CIP (e.g., Six Sigma).
• Drive product performance data analysis, reporting and corrective actions.
• Develop and implement supplier quality management systems and processes.
Experience & Training:
• Bachelors degree in Engineering or Science required
• 10 to 20 years quality assurance or quality engineering background is required
• Experience with medical device or regulated industry is required
• Experience with formal development methodologies 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 Engineering technologies. 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.