Quality Assurance Associate

alcon; Surrey Heath; On-site; GBP 32,000 - 44,000; Full time

Benefits offered by this job

Health insurance

Pension

Bonus

Job summary

Alcon UK & Ireland Quality & Regulatory Affairs is seeking a Quality Assurance Associate to support maintenance of the QMS and ensure compliance with GxP, ISO 13485, and local regulations.

You will perform product release, audits, training, and CAPA to drive continuous improvement, with onsite work at HO Watchmoor Park. This role offers a collaborative environment and opportunities to advance in quality systems within a global medical device company.

Qualifications

• Open to graduates with a science degree, industry experience a plus but not a must.
• Autonomous and self-driven.
• Innovative mindset with the ability to identify and implement process improvements.
• The ability to be onsite in HO Watchmoor Park 5 days per week.

Responsibilities

• Maintain and monitor the Quality Management System (QMS) to ensure compliance with local regulations, GxP and ISO 13485.
• Perform root cause analysis and define SMART CAPA with effectiveness checks; participate/lead quality projects.
• Carry out product release, monitor storage conditions and redress activities in compliance with relevant standards.
• Lead and participate in audits of suppliers and internal processes; ensure proper training mapping and records in SAP IRIS.

Skills

Autonomous

Innovative mindset

Workflow optimization

Education

Science degree

Job description

Quality Assurance Associate

At Alcon, we're passionate about enhancing sight and helping people see brilliantly. With more than 25,000 associates, we innovate fearlessly, champion progress, and act swiftly to impact global eye health. We foster an inclusive culture, recognizing your contributions and offering opportunities to grow your career like never before. Together, we make a difference in the lives of our patients and customers. Are you ready to join us?

This role is part of Alcon's UK and Ireland Quality & Regulatory Affairs function, a team that ensures our products are in compliance with global and local regulations, GxP as well as ISO 13485 requirements and meet the strictest standards of quality as we help people see brilliantly. The Sr. Associate, Quality Assurance is primarily responsible for supporting maintenance and monitoring of the Quality Management System to ensure compliance with Alcon policies and local and international regulations.

Typical responsibilities in this role will include:

• Supporting the Maintenance and Monitoring of the Quality Management System. This includes assessing and performing root cause analysis as per Alcon's non-conformance process and define SMART CAPA and effectiveness check. In addition, the job holder also participate/ lead quality projects. The job holder is responsible to perform routine work such as product release, monitoring of storage conditions and redress activities in compliance with local regulatory, GxP as well as ISO 13485 requirements.
• Performs corrective actions as well as field safety corrective actions, communicates with authorities and affected customers.
• Within the supplier management process, the job holder is responsible for qualification and risk evaluation of suppliers and establishes quality assurance agreements with suppliers. The job holder, after completing the required qualification steps, is performing internal as well as external audits as an Alcon auditor. This includes the subsequent monitoring of audit measures.
• Acts as the UK Facility Records Administrator ensuring that GxP records maintained by the site are managed in accordance with Alcon's global procedures.
• Ensure the annual training mapping exercise and training completion is performed for all roles within Alcon UK, including Operational Manager review of role-based training requirements.
• Work with Subject Matter Experts from across all Alcon UK functions to support the continuous improvement of training course development and delivery including the scheduling and facilitation of instructor-led training.
• Maintain records, in accordance with Good Documentation Practices and ALCOA++ principles, compliant with Alcon's Global Training Procedure, for the creation, assignment and amendment of training curricula.
• Complete assigned activities within SAP IRIS as directed by the Director of QRA and Quality Manager.
• Completion of effective investigation of Nonconformance / DCT records within time with procedurally defined timelines, including the follow-up of actions and effectiveness checks.
• Participate in Site Internal, Internal and External Audits in accordance with the principles described in the international standard ISO 19011 Guidelines for auditing management systems, and Alcon's Quality System Procedures.
• Undertake any other duties or projects as requested by the Line Manager, commensurate with the grade and level of responsibility for this role.

What you'll bring to Alcon:

• Education/Experience: Open to graduates with a science degree, industry experience a plus but not a must
• Autonomous and self-driven.
• Innovative mindset with the ability to identify and implement process improvements.
• Skilled at streamlining and optimizing workflows for efficiency.
• The ability to be onsite in HO Watchmoor Park 5 days per week.

How You Can Thrive At Alcon

• A competitive salary package with fixed salary, bonus, pension and health insurance
• A flexible work environment with competent and committed colleagues. We enjoy working together in a good and respectful manner, and we celebrate our common successes
• See your career like never before with focused growth and development opportunities