Senior Executive, Quality Systems

at  Alcon

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 Executive supporting Quality Systems, you will be responsible for Quality Compliance, GxP training and Record Management for the site to ensure that quality system is compliant to ISO 13485, MDSAP, EU MDR, Alcon Standards and Policies Tuas. In this role, a typical day will include:

• 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.
• Coordinate activities and compliance to all applicable standards (e.g. ISO 13485, MDSAP) and regulatory requirements (e.g. EU MDR, EU MDD)
• Perform Site’s investigation (NCR, SAR, OOS, Complaints, etc) and Site’s WI/SOP/Gap Assessment/Impact Assessment.
• Identify, anticipate, investigate and drive resolution on quality compliance issues and communications.
• Coordinate/Manage Management Review, consolidate monthly data and prepare monthly summary report for site quality metrics reporting into Global Platform.
• Assess change control for regulatory impact and quality representative for life cycle of product labeling and artworks.
• Support, perform and/or lead internal audits, supplier audits and external/regulatory audits, including updating and maintenance of system related to audits.
• Work with cross-functional teams to resolve operational quality issues Lead activities and compliance to all applicable standards (e.g.Lead and manage day to day operation of Record Management activities, GxP Training activities and oversight Training System for compliance to SOP, Standards and Regulations. (as assigned)
• Perform, review and/or approve Site’s investigation (NCR, SAR, OOS, Complaints, etc), Site’s WI/SOP/Gap Assessment/Impact Assessment.
• Supervise / Provide guidance, coaching and training to the team as required.
• Work together with supervisor to improve competency of the team.
• Provide assistance to supervisor in preparing, presenting and managing cost centre budget and forecast accuracy.
• Supervise and responsible for team’s Objective setting, attendance, performance review, and development plan.
• Backup to the function Manager.
• Performs any other duties as assigned by Supervisor according to business needs.
• Adhere to Alcon standards, in particular quality, ethical, health, safety and environment (HSE) and Business Information Management (BIM) standards.

What You Will Bring to Alcon:

• Degree in any engineering
• Min 7 years of relevant experience preferably knowledge in GMP and ISO13485

How You Can Thrive At Alcon:

• 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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• 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.
• Coordinate activities and compliance to all applicable standards (e.g. ISO 13485, MDSAP) and regulatory requirements (e.g. EU MDR, EU MDD)
• Perform Site’s investigation (NCR, SAR, OOS, Complaints, etc) and Site’s WI/SOP/Gap Assessment/Impact Assessment.
• Identify, anticipate, investigate and drive resolution on quality compliance issues and communications.
• Coordinate/Manage Management Review, consolidate monthly data and prepare monthly summary report for site quality metrics reporting into Global Platform.
• Assess change control for regulatory impact and quality representative for life cycle of product labeling and artworks.
• Support, perform and/or lead internal audits, supplier audits and external/regulatory audits, including updating and maintenance of system related to audits.
• Work with cross-functional teams to resolve operational quality issues Lead activities and compliance to all applicable standards (e.g.Lead and manage day to day operation of Record Management activities, GxP Training activities and oversight Training System for compliance to SOP, Standards and Regulations. (as assigned)
• Perform, review and/or approve Site’s investigation (NCR, SAR, OOS, Complaints, etc), Site’s WI/SOP/Gap Assessment/Impact Assessment.
• Supervise / Provide guidance, coaching and training to the team as required.
• Work together with supervisor to improve competency of the team.
• Provide assistance to supervisor in preparing, presenting and managing cost centre budget and forecast accuracy.
• Supervise and responsible for team’s Objective setting, attendance, performance review, and development plan.
• Backup to the function Manager.
• Performs any other duties as assigned by Supervisor according to business needs.
• Adhere to Alcon standards, in particular quality, ethical, health, safety and environment (HSE) and Business Information Management (BIM) standards