Alcon
Medical Devices
Director,QualityAssuranceCompliance
“Director, Quality Assurance Compliance at Alcon. Skills: Quality Assurance, Compliance, Leadership, Quality Systems. Lead and direct teams. Develop and implement strategies”
What You'll Achieve.
Ensuring compliance with current Good Manufacturing Practices (cGMP), Health Authority, Alcon Quality Manual, and International Organization for Standardization (ISO) standards; Achieve departmental goals; Ensure compliance with cGMP, Health Authority, and Alcon Quality Manual requirements, as well as ISO standards; Ensure compliance with regulatory requirements; Ensure comprehensive and timely investigation into non-conforming supplier related events; Ensure site representation during discussions / communications about new and evolving regulatory requirements, global quality initiatives, and other quality community topics; Ensuring compliance with governing regulations and corporate procedures; Ensuring compliance with regulatory requirements; Contributing to the overall compliance of the organization
Industry & Context.
Advanced problem-solving
Travel: 5%, Relocation: Yes, Sponsorship Assistance: No, Work Location: Onsite – 5 days per week at the Houston Manufacturing facility
What They're Looking For.
Must Have
Bachelor's Degree or Equivalent years of directly related experience, 10 Years of Relevant Experience, 6 Years of Demonstrated Leadership, Ability to fluently read, write, understand and communicate in English
What You'll Do.
Lead and direct teams
Develop and implement strategies
Manage Quality Systems
Manage Supplier Quality Management processes
Facilitate Quality Strategy implementation
Support governance processes
Identify opportunities for improved process efficiencies
Implement process changes
Conduct training sessions
Manage quality systems
Provide oversight of Supplier Quality activities
Approve departmental budgets
Approve major projects
Lead project activities
Plan project activities
Execute project activities
Lead audit preparation activities
Participate in external audits
Provide oversight for Site Internal Audit
Provide oversight for External Audit
Provide oversight for Supplier Quality programs
Provide oversight for Escalation / Field Action Assessment / Recall
Provide oversight for Management Review
Provide oversight for Document Management
Provide oversight for periodic reporting
Interact with Global Compliance
Interact with Quality Systems
Interact with External Supplier Quality groups
Ensure site representation
Drive continuous improvement initiatives
Enhance site quality system
Enhance product quality
Adhere to Good Practice (GxP) regulations
Follow Standard Operating Procedures (SOPs)
Maintain accurate documentation
Maintain complete documentation
Ensure rigorous quality control
Complete all required training
How You'll Work.
Team & Collaboration
Work together with colleagues to share standard methodologies and discoveries
Communication Scope
Communication skills
Process & Methodology
Strategic planning, Project management
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