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Senior Quality Operations Manager

1 week ago

Singapore Alcon MX Full time

Alcon MX is a global leader in eye care, driven by the meaningful work we do to help people see brilliantly. We innovate boldly, champion progress, and act with speed to make an impact in the lives of our patients and customers.

We foster an inclusive culture and are looking for diverse, talented individuals to join our team. As a Senior Quality Operations Manager, you will oversee and ensure that the manufacturing of medical devices produced meets the requirements of Alcon standards, 21 CFR Part 820, Part 11, ISO 13485, the Medical Device Regulation (MDR), and other applicable regulations and standards.

This role involves ensuring quality objectives set by management are met and complying with Alcon, QMS, and Safety requirements. You will also contribute to the site Quality Management System by implementing it effectively through self-inspections, performance metrics, and management reviews.

  • Meet quality objectives set by management & comply with Alcon, QMS and Safety requirements.
  • Contribute to the site Quality Management System by ensuring its effective implementation in the organization through self-inspections, performance metrics, and management reviews.
  • Establish and manage processes for Computer System Validation (CSV) & Non-Conformances, including training effectiveness and oversight on execution.