Senior Engineer, Quality Operations
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.
As a Senior Engineer, Quality Operation you are tasked to assess and monitor supplier quality thereby ensuring that the material or product provided are free of defects and in compliance with specifications. Supplier quality engineers communicate between internal stakeholders and suppliers to address and resolve quality issues, providing technical input and guidance on process enhancements and improvements. By doing so, this position ensures the quality of the medical devices produced on site meets the requirements of Alcon standards,21 CFR Part 820, Part 11, ISO 13485, the Medical Device Regulation (MDR), MDSAP and other applicable regulations and standards at Tuas. In this role, a typical day will include:
Responsibilities
- Responsible for supplier quality management and is the primary quality interface with the suppliers.
- Supplier Selection - identify and select suitable supplier to ensure all aspects of quality, capability, pricing, delivery and environment meet Alcon requirements.
- Supplier Qualification - conduct new supplier qualification thru the process of capability matching, supplier risk assessment, supplier self-assessment, onsite qualification audit and supplier quality agreement accordance with Alcon requirements
- Supplier Monitoring - assess, monitor and communicate Supplier performance, escalate issue when necessary.
- Perform thorough supplier audits and assessments of their processes and QMS drives improvement. Identify supplier-related problems and improvement opportunities.
- Work with internal stakeholders and suppliers on resolving of quality issues to closure for all incoming & production rejects through SAR process.
- Review and approve supplier investigations by ensure proper investigation and corrective actions execution.
- Monitoring and drive timely closure of the Supplier Action Request (SAR).
- Cross-functionally coordinates with the Procurement to perform periodic business review with selected suppliers.
- Perform and review all supplier quality related SOPs / Form changes and Gap
- Assessments Support internal and external audits and is responsible for audit finding closure, as required.
- Work with cross-functional teams to resolve operational quality issues
- Trend, analyze and monitor key performance indicators, suggest improvements and escalate to supervisor/management as necessary
- Identify improvement opportunities and lead/support the implementation activities to improve performance and efficiency.
- Meet quality objectives set by management & comply to Alcon, QMS and Safety requirements. Drive and support supplier CIP (Continuous Improvement Program) by using quality tools to improve manufacturing process and product quality
- Drive full assessment for effectiveness of supplier process control plans, measures and activities Serve as Quality representative on project teams for new product design transfers
- Dive deep and maintain the technical understanding needed to actively contribute to engineering and product decision-making.
- Responsible as Super User in SAP IRIS for Supplier Quality Management relevant activities to meet Alcon’s requirement.
- Perform any other duties/ projects/ assignments assigned by Supervisor as per Business Needs.
What You'll Bring to Alcon
- Min diploma or degree
- 1-3 years relevant experience in manufacturing/pharma or medical device industry preferred
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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