Senior Quality Assurance Associate

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. Major Accountabilities Duties are listed in order of greatest importance. Other responsibilities may be assigned. Quality Management System Drive and maintain the processes and procedures needed for an effective Quality Management System, covering all necessary GxP, Quality regulations and standards, including but not limited to, self‑inspections, supplier qualifications, CAPA process and SOP compliance. Implement Alcon Quality System Procedures (QSPs, MSPs, FSPs) at local level and ensure local SOPs and/or work instructions are in place if needed, including adequate and timely GxP training assignments. Manage local deviations and change controls through identification, investigation, root cause determination, documentation, follow up and closure of actions including escalation to global as require. Manage and implement document and records control according to procedures. Lead continuous improvement efforts through the identification, follow‑up, and closure of Corrective and Preventive Actions (CAPAs), including management of local CAPA process, and fulfilment of the role of CAPA coordinator. Support and execute market recalls and/or actions according to procedures and elevate as required. Management of product hold processes, including interactions with 3PLs and communication with the local business. Gather and report Key Quality Indicators in accordance with Corporate QA requirements. Audits / Inspections Coordinate and prepare for internal (self‑inspection), external (supplier) audits and Health Authorities / Notified Bodies Inspections. Coordinate with relevant stakeholders on inspection/audit observation responses and ensure responses are within HA / NB timeline. Lead and participate internal and external audits as a qualified auditor and drive CAPA resolution (as applicable). Supplier Management Ensure GxP suppliers are properly qualified, monitored and processes are compliant with Alcon Quality requirements (e.g. warehouse, distribution, redress / re‑labelling). Collaborate with cross‑functional teams to manage and drive improvement on 3PLs in accordance with Alcon’s quality standard. Issue quality notification to 3PL and ensure appropriate supplier corrective actions are taken at the supplier end. Complaint Management Manage assessment of all complaints received in Australia and New Zealand for reportability to local regulators (TGA & Medsafe). Coordinate responses to regulator questions regarding post‑market activities. Coordinate return of complaint samples, including facilitating replacement or refund, as applicable. Provide support with submission and tracking of product complaints, as required. Support product complaint activities as required. Others Collaborate cross‑functional teams and 3PLs to resolve quality enquiries and iDoCs. Maintain current knowledge of local and international regulatory and legislative requirements and trends to ensure that technical support on all quality related matters is provided to the country. Support Regulatory Affairs tasks or improvement projects across the local QRA function as required. Other responsibilities as per management direction. Complies with all policies and standards. Education / Qualifications Minimum / essential: Bachelor degree in Science, Pharmacy or related discipline. Skills / Experience 3-5 years experience working in a similar role for a medical device company. Sound knowledge of ISO standards relating to Quality Management Systems (i.e. ISO 13485 & ISO 9001). Strong written and verbal communication skills. Strong knowledge of MS Office packages (e.g. Excel, Outlook, Word, Powerpoint). 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. #J-18808-Ljbffr