Sr Associate Quality Assurance Compliance

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 youll 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 and we are looking for a QA Analyst in Puerto Rico. The Sr. Associate Quality Assurance Compliance is responsible for providing tactical site support to ensure compliance initiatives are developed implemented and maintained according to Alcon requirements and International Regulations. The Sr. Associate Quality Assurance Compliance specialist contributes to the site compliance and regulatory affairs activities to the site internal audit and external regulatory agencies / notified bodies audits and to the quality reporting and compliance forums supporting operation at the Johns Creek GA USA Manufacturing Facility.

All quality processes will be in compliance to 21CFR 820 ISO 13485 and Alcon requirements.

In this role a typical day will include:

• Identify and monitor relevant guidance documents international standards or consensus standards and provide interpretive assistance to the site.
• Conduct regular training sessions to ensure that site personnel are knowledgeable in the latest regulatory requirements and compliance obligations. Develop and deliver training materials on domestic and international laws guidelines and standards applicable to the Johns Creek Manufacturing Facility. Obtain and distribute updates on these laws guidelines or standards and incorporate them into training programs to maintain alignment with current regulatory expectations.
• Independently coordinates site gap assessments with affected departments against new/revised corporate procedures regulatory actions etc. reports identified discrepancies and ensures followup on assigned site corrective actions for identified gaps. This includes tracking and routine reporting of site status during management oversight meetings as requested.
• Prepares final Quality Council and Management Review meeting presentations based on metrics/topics submitted by departments. Reviews the data submitted to ensure procedural requirements are satisfied. Facilitates / leads the meetings. Coordinates followup activities including meeting minutes and summaries.
• Manages the preparation and reporting of routine compliancerelated metrics for various compliance forums related to Sites Quality compliance as assigned.
• Leads /supports internal audits for the site including the planning and closeout activities.

• Completes regulatory submission activities for the site as requested by Global RA Management Global RA Country RA Global Quality Systems Site Management.
• Assists with Health Authority and other external audits/inspections performed at the site. This can include coordination of hospitality items participation in the strategy room and/or audit room and followup activities related to audit responses.
• Supports / leads quality systems and compliance projects and initiatives: Alcon Global QS requests developing knowledge of the quality systems and industry standard requirements benchmarking on best practices obtaining / maintaining Regulatory Assessor Certification conducts regulatory assessments of internal changes leads escalation activities as needed and assigned.
• Other duties as assigned by area management.
• Is consistently engaged on a daily basis with teammates

WHAT YOULL BRING TO ALCON:

• Bachelors degree (preferred Masters degree) in science or engineering discipline
• Highly preferred Quality / Compliance related Certification (ex. ASQ SixSigma etc.
• Five years (preferred seven) in quality or compliance arena in medical device pharmaceutical or related industry
• The ability to fluently read write understand and communicate in English

Work hours: MoFr 8hr

Travel Requirements: None

Relocation assistance: No

Sponsorship (Work Visa); No

PREFERRED QUALIFICATIONS / SKILLS / EXPERIENCE:

• High degree of knowledge understanding and capability of applying Quality Systems Requirements: ISO13485 MDSAP EU MDR/MDD Good Manufacturing Practices (GMP) Chinese FDA GMPs for Medical Devices and ISO14971. Preferred experience with Class II and Class III devices.
• Experience working directly with FDA Notified Bodies and/or international health authorities.
• General working knowledge of manufacturing and QMS support systems such as ERP LIMS document repositories etc.
• Excellent communication skills (both written and verbal).
• Experience in conducting technical investigations with a high degree of RCA tools understanding. Technical and analytical aptitude.
• General working knowledge of office related computer programs such as Word Excel PowerPoint etc.
• General working knowledge of basic statistical techniques.

HOW YOU CAN THRIVE AT ALCON:

• Join Alcons mission to provide outstanding innovative products and solutions to improve sight improve lives and grow your career!
• Collaborate with teammates to share standard processes and findings as work evolves!
• See your career like never before with focused growth and development opportunities!
• Alcon provides robust benefits package including health life retirement flexible time off for exempt associates PTO for hourly associates and much more!

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Alcon is an Equal Opportunity Employer and participates in EVerify. 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 and let us know the nature of your request and your contact information.