Senior Quality Engineer in London

A brighter future awaits you. CooperVision is one of the world's leading manufacturers of soft contact lenses with a presence in over 100 countries. Being part of CooperVision means helping improve the way people see each day. It's more than making contact lenses; it's about giving lens wearers freedom and confidence to move about their daily lives. We're all about bright futures for our people and those who wear our contact lenses.

Scope: Reporting directly to the Quality Engineering Manager, the Senior QA Engineer shall ensure that the introduction of all new projects, equipment, processes, and products within the business meet the requirements of the Quality Management System using data analysis, risk management, and quality planning.

Job Summary: The Senior Quality Engineer shall act as the principal contact for quality and compliance activities during new product introductions, new equipment and processes, quality systems, as well as continuous improvement projects. The Senior QE will provide support to R&D, GTIG, PTIG, and the Business Units (BUs) functions in all quality-related aspects of lens development, manufacturing, and subsequent secondary packaging activities to ensure best practice and standardisation opportunities across all sites are identified.

Essential Functions & Accountabilities:

• Actively participate and assist in the development of the strategy and validation plan for the implementation of new equipment and processes, products, new technologies, and continuous projects for existing processes and products.
• Provide the appropriate quality technical support to new product and process development and continuous improvement projects to ensure they meet the requirements of the Quality Management System.
• Responsible for sampling plan preparation, quality plan/control plan development, test procedures implementation, and statistical data analysis.
• Use of quality/statistical tools for troubleshooting and identification of product and process improvement.
• Evaluate process changes for potential impact on the business and recommend their incorporation into the current and future production lines to improve product/process quality.
• Lead quality initiatives and participate in multi-disciplinary teams engaged on the above activities.
• Review and approval of process validation activities such as IQOQ and PQ protocols and reports as required by the project team.
• Review and update SOPs and project-related documentation.
• Assist in developing and execution and reporting of engineering studies for product and process characterisation and development.
• Review and approval of engineering studies and reports.
• Review and approval of FAT and SAT documents.
• Actively participate in the design transfer process during product transfer from R&D into lens manufacturing facilities and subsequent design realisation through the packaging and distribution sites.
• Actively participate in product and process site-to-site transfer activities.
• Actively contribute to projects activities such as risk assessment and project meetings.
• Assist Project Engineers in ensuring the correct and appropriate evaluation of the processes using a risk-based methodology.
• Involvement in the planning and preparation of engineering changes orders (ECO).
• Conducting NCR/quality issue investigations related to projects in conjunction with the BU and liaising with the BU(s) to ensure the appropriate product disposition is implemented.
• Understanding of the elements of software validation and identification of processes/systems requiring software validation.
• Actively participate and support in the documentation preparation for regulatory submissions required of changes.
• Participate and support in regulatory agency inspections of the facilities and ensure corrective actions are performed as required.
• Create a culture of quality, awareness, teamwork, and cooperation with all groups and within the facility.
• Oversee and provide guidance to ensure that all activities performed are in accordance with Quality System and regulatory requirements to be in an audit-ready state.

Travel Requirements: Travel to other domestic and international CooperVision sites (5%).

Knowledge, Skills and Abilities:

• A strong driver, communicator, and influencer whilst quality will be top of their agenda it may not be the priority for other members of the team.
• Highly motivated self-starter and responsible person. Proactive and self-directed.
• Excellent planning and organisational skills. Able to successfully manage multiple projects.
• Uses rigorous logic and methods to solve difficult problems with effective implementable solutions.
• Demonstrates effective use of written and verbal communication skills to meet job requirements.
• Knowledge of and experience with quality systems and the eQMS system.
• Applied knowledge of statistical tools: acceptance sampling, SPC etc.

Experience and Education:

• Preferably five years contact lens or process knowledge in QA and/or manufacturing.
• Knowledge of Lean manufacturing and/or Six Sigma methodology.
• Strong current grasp of regulatory and GMP requirements – knowledge of FDA processes specifically would be a distinct advantage.
• Bachelor's degree in engineering, science, or related field or proven quality background – ideally five years experience in the medical or life sciences sectors.
• Current driving license.

What we offer: You'll receive competitive compensation and a fantastic benefits package including 25 days holiday, pension scheme, access to our wellness platform to support you in mental health and wellbeing, a discounted contact lens scheme, and much more! We are committed to our employees' personal and professional development and offer extensive training to support your career growth and help every individual to reach their full potential.

What you can expect: As a CooperVision employee, you'll be welcomed into a diverse and progressive global business. We appreciate how important fostering an inclusive culture is and how different perspectives add value and contribute to our success.

All suitably qualified applicants will receive equal consideration and opportunities from CooperVision.