Batam, Indonesia
7 days ago
Manager I, Quality Assurance Compliance

At Alcon, we're passionate about enhancing sight and helping people see brilliantly. With more than 25,000 associates, we innovate fearlessly, champion progress, and act swiftly to impact global eye health. We foster an inclusive culture, recognizing your contributions and offering opportunities to grow your career like never before. Together, we make a difference in the lives of our patients and customers. Are you ready to join us?

The Manager I, Quality Assurance Compliance is primarily responsible for leading and implementing compliance programs related to Quality Assurance, ensuring adherence to quality standards and regulatory practices. Specifics include:

Serve as the Self-Inspection Coordinator, managing planning, execution, reporting, and follow-up of self-inspection audits.Ensure audits are performed according to Quality System requirements; coordinate internal and external QMS audits (e.g., Corporate, Health Authority, Notified Body).Support external supplier audits.Act as Site Coordinator for the TrackWise-ACE Audit system, ensuring timely closure of audit reports and effectiveness of corrective/preventive actions.Represent the site in the Global Audit Community.Deliver training and qualification for self-inspection auditors.Lead the Management Review and Quality Council Meetings, including scheduling, documentation, and action tracking.Maintain and follow up on the Compliance Tracker.Participate in quality compliance improvement initiatives.Support IMPACD and external standards processes.Involved in product recall processes, including FAA and mock recalls.Perform additional duties as assigned.Comply with HSE (Health, Safety & Environment) policies and report HSE concerns as appropriate.

Why Join Us:

Opportunity to work with a leading global medical device company.Collaborate with a diverse and talented team in a supportive work environment.Competitive compensation package and comprehensive benefits.Continuous learning and development opportunities.

  

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