Head of Quality Assurance and Compliance
7 days ago
At Alcon, we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly, champion progress, and act with speed as the global leader in eye care. Here, you'll be recognized for your commitment and contributions and see your career like never before. Together, we go above and beyond to make an impact in the lives of our patients and customers. We foster an inclusive culture and are looking for diverse, talented people to join Alcon.
Key Responsibilities- Quality Systems and Operations: Develop, maintain, and improve quality systems and assure products meet established specifications and are in compliance with various quality and regulatory standards.
- Quality Leadership: Direct and guide with respect to product, process, and system quality requirements and standards, oversees non-conformance resolution, continuous improvement, quality plan development, risk assessments, change management, and qualification/validation activities.
- Quality Management: Participate in the design, implementation, monitoring and maintenance of an effective Quality Management System.
- Quality Council and Review: Chair the site Quality Council and Quality Management Review meetings.
- Site Leadership: Partner with cross-functional Site Leadership team to establish key quality and performance objectives, corresponding resource requirements, budgets, and forecasts/plans to ensure they are met.
- Regulatory Compliance: Identify and direct activities to ensure organizational compliance to FDA regulations, ISO Requirements, ISO standards, and internal policies/procedures.
- Quality Improvement: Direct and implement the organizations Quality Improvement Plan in accordance with the mission and strategic goals of the organization, federal and state laws, and regulations and standards.
- Employee Training and Development: Advise employees and management team on the applicable regulations and standards, Alcon policies, and all other relevant regulatory requirements and notify and take management of any identified patient safety or regulatory risks.
- Quality Budget Management: Manage the Quality budget to ensure spending is within department plans.
- PRRC Delegate: Serves as delegate to the PRRC for Device Release Conformance to QMS per Article 15 3 (a) and for Trend Reporting per Article 15 3 (d) and Article 88.
- Education: Bachelor's Degree (Concentration in Engineering, Science preferred)
- Language: The ability to fluently read, write, understand and communicate in English
- Experience: 12 Years of Relevant Experience
- Leadership: 8 Years of Demonstrated Leadership
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