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, 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 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 follow-up 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 follow-up activities, including meeting minutes and summaries.
• Manages the preparation and reporting of routine compliance-related metrics for various compliance forums, related to Site’s Quality compliance, as assigned.
• Leads /supports internal audits for the site, including the planning, execution 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 follow-up 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 YOU'LL BRING TO ALCON:

• Bachelor’s degree (preferred Master’s degree) in science or engineering discipline
• Highly preferred Quality / Compliance related Certification (ex. ASQ, Six-Sigma, 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: Mo-Fr, 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 intern