Supervisor, Quality Assurance

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 Quality Assurance Supervisor, you are responsible for the timely and compliant release of medical devices, and for the performance of the QA Release function. You will monitor key performance indicators related to the QA release processes, analyze trends, and implement corrective actions to improve performance and efficiency along with troubleshooting quality problems impacting product release. This role is responsible for the QA release specialists.

In this role, a typical day will include:  

• Lead and manage a team of QA release specialists responsible for the timely and compliant release of medical devices, ensuring adherence to FDA regulations and company policies.

• Develop, implement, and maintain robust QA release processes and procedures using TrackWise and SAP systems, ensuring accuracy and efficiency throughout the release lifecycle.

• Collaborate closely with cross-functional teams, including Manufacturing, MS&T, Regulatory Affairs, and Quality Assurance, to coordinate and streamline QA release activities.

• Conduct regular audits and reviews of QA release documentation, ensuring completeness, accuracy, and compliance with regulatory requirements.

• Serve as a subject matter expert on FDA regulations, TrackWise, SAP, and other relevant systems, providing training and support to team members as needed.

• Monitor key performance indicators (KPIs) related to QA release processes, analyze trends, and implement corrective actions to improve performance and efficiency.

• Participate in the development and implementation of CAPA (Corrective and Preventive Action) plans related to QA release activities, ensuring timely resolution of issues and non-conformities.

• Stay abreast of industry trends, regulatory changes, and best practices in quality assurance and QA release management, incorporating updates into existing processes and procedures.

• Collaborate with external auditors and regulatory agencies during inspections and audits, providing documentation and support as required.

• Interfaces: Coordinate with other departments to accomplish objectives. Work with Production and Planning to prioritize the release of products.

• Assist Production, Engineering, and MS&T to trouble shoot quality problems.

• Work with Material Control to identify, locate, and hold production lots, as needed.

• Provide guidance, coaching, and mentorship to team members, fostering a culture of continuous learning, accountability, and quality excellence.

• Recruit, onboard, mentor, and assess team members.

• Offer consistent support and feedback, in structured and casual settings. Evaluate both individual and team skills regularly.

• Create tailored development plans to facilitate continuous personal and professional growth.

• Address employee issues promptly and fairly, resolving conflicts and working with HR when needed for counseling or disciplinary measures.

WHAT YOU’LL BRING TO ALCON:  

• Bachelor’s Degree or Equivalent years of directly related experience (or high school +10 yrs; Assoc.+6 yrs; M.S.+0 yrs)

• 2 Years of Relevant Experience

• The ability to fluently read, write, understand and communicate in English

• Significant Technical/leadership experience and/or advanced education in a relevant field may be considered for less experience.

PREFERRED QUALIFICATIONS:  

• 1 Year of Demonstrated Leadership

• Extensive knowledge of cGMP regulations, regulatory requirements, and international standards for the manufacturing of medical devices.

HOW YOU CAN THRIVE AT ALCON:  

• See your career like never before with focused growth and development opportunities.

• Join Alcon’s mission to provide outstanding innovative products and solutions to improve sight, improve lives, and grow your career!

• Alcon provides robust benefits package including health, life, retirement, flexible time off and much more.

Education / Experience

Minimum:

• Bachelor’s Degree or Equivalent years of directly related experience (or high school +10 yrs; Assoc.+6 yrs; M.S.+0 yrs)
• 2 Years of Relevant Experience
• The ability to fluently read, write, understand, and communicate in English

Preferred:

• 1 Years of Demonstrated Leadership
• Extensive knowledge of cGMP regulations, regulatory requirements, and international standards for the manufacturing of medical devices.

Alternative combination: Significant Technical/leadership experience and/or advanced education in a relevant field may be considered for less experience.

Languages: Fluent English

ATTENTION: Current Alcon Employee/Contingent Worker

If you are currently an active employee/contingent worker at Alcon, please click the appropriate link below to apply on the Internal Career site.

Find Jobs for Employees

Find Jobs for Contingent Worker

Alcon is an Equal Opportunity Employer and participates in E-Verify. Alcon takes pride in maintaining a diverse environment and our policies are not to discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity, marital or veteran status, disability, or any other legally protected status. Alcon is also committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an email to alcon.recruitment@alcon.com and let us know the nature of your request and your contact information.