Associate Director, Quality Management Systems
AlconAbout the role
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 an Associate Director, Quality Management Systems you will be trusted to work on ensuring continued compliance and effectiveness of Alcon's Quality Management Systems. This role will drive harmonization and standardization of the Quality Management Systems at Alcon across all Franchises, inclusive of incorporating new standards and acquisitions. This position will monitor KPIs and support the community networks, inclusive of supporting the supplier management program.
This position will work in our Fort Worth, Texas location a typical day will include:
- Ensure global QMS procedures comply with applicable regulations and standards including but not limited to: 21 CFR 210/211, 21 CFR 820, EUMDR, ISO 13485, ANVISA, ICH Q10.
- Monitor internal and external Health Authority / Notified body audit trends and feedback for timely implementation into the QMS.
- Document and investigate QMS non-conformance / CAPAs
- Ensure implementation of new/revised regulatory QMS requirements into the Quality Management System framework, including integration of QMS activities related to acquisitions.
- Support monitoring of supplier audit program, including risk to Alcon supply chain, by ensuring adherence to regulatory requirements and closure of corrective action items.
- Lead cross-functional meetings related to global supplier performance monitoring issue resolution and/or supplier network initiatives.
- Lead continuous improvement initiatives for QMS.
- Establish and implement programs to drive quality expertise and compliance in key core QMS (CAPAs, NCIs, Audits, Supplier Quality, Change Control).
- Support the Global QMS Change Control Review Board (quality system changes)
- Partner with the Alcon’s Quality Networks to drive integration of acquisitions into the Alcon QMS framework.
WHAT YOU'LL BRING TO ALCON:
- Bachelor’s Degree or Equivalent years of directly related experience (or high school +15 yrs; Assoc.+11 yrs; M.S.+4 yrs; PhD+3 yrs)
- The ability to fluently read, write, understand, and communicate in English
- 7 Years of Relevant Experience
- 5 Years of Demonstrated Leadership
HOW YOU CAN THRIVE AT ALCON:
- Benefit from working in a highly collaborative environment.
- 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!
- Travel Requirement - 10%
- Relocation assistance: No
- Sponsorship available: Yes
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.
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