Job Summary
:
The Senior Quality Engineer shall act as the principle 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.
The Senior Quality Engineer, working as part of a team, shall also maintain and develop existing Quality Management System procedures and processes through monitoring and determining product and process capability and leading continuous improvement projects.
Essential Functions & Accountabilities:
1. 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.
2. 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.
3. Responsible for Sampling Plan Preparation, Quality Plan/ Control Plan Development, Test procedures Implementation and Statistical Data Analysis.
4. Use of quality/statistical tools for troubleshooting and identification of product and process improvement.
5. Evaluate process changes for potential impact on the business and recommending their incorporation into the current and future production lines to improve product/process quality.
6. Lead quality initiatives and participate in multi-disciplinary teams engaged on the above activities.
7. Review and approval of Process Validation activities such as: IQ,OQ and PQ protocols and reports as required by the project team. This may include NCR and Deviations process during the execution of the project.
8. Review and update SOPs and project related documentation.
9. Perform eQMS document submission (DCR, DCO, ECO, QP, APP, .
10. Assist in developing and execution and reporting of Engineering Studies for product and process characterisation and development.
11. Review and approval of Engineering studies and reports.
12. Review and approval of FAT and SAT documents.
13. Actively participates 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.
14. Actively participate in product and process site to site transfer activities.
15. Actively contributes in related to projects activities as Risk Assessment and Project meetings.
16. Assist Project Engineers in ensuring the correct and appropriate evaluation of the processes using a Risk based methodology.
17. Involvement in the planning and preparation of Engineering Changes Orders (ECO).
18. Conducting NCR/Quality Issue investigations related to project in conjunction with the BU and liaising with the BU(s) to ensure the appropriate product disposition is implemented.
19. Understanding of the elements of software validation and identification of processes/systems requiring software validation.
20. Actively participates and supports in the documentation preparation for Regulatory Submissions required of changes.
21. Participates and support in Regulatory Agency Inspections of the facilities and ensures corrective actions are performed as required.
22. Creates a culture of quality awareness, teamwork and cooperation with all groups and within the facility.
23. 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
24. Travel to other Domestic and International CooperVision sites (~5%)
Knowledge, Skills and Abilities
25. 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.Strength of character but able to achieve objectives through influence and negotiation rather than confrontation.
26. Highly motivated, self-starter, and responsible person.Proactive and self-directed.Have the initiative and drive to develop and implement new concepts.
27. Excellent planning and organisational skills.Able to successfully manage multiple projects.Ability to manage and prioritise numerous and complex projects utilising effective time management and organisational skills.
28. Uses rigorous logic and methods to solve difficult problems with effective, implementable solutions and ability to read and understand technical material.
29. Demonstrates effective use of written and verbal communication skills to meet job requirements, including the ability to write/speak clearly and succinctly to get messages across with the desired effect/result. Practices attentive and active listening and demonstrates the ability to hear other points of view.
30. Knowledge of and experience with Quality Systems and the eQMS system.Knowledge of FDA and other current Standards/Regulations.
31. Applied knowledge of statistical tools:Acceptance Sampling, SPC, etc.
Work Environment
32. The post operates in an office environment however the role may involve entering the ASEC areas and to be “gowned up”.
33. Flexibility of location (any Company site).
Experience and Education
34. Preferably five years contact lens or process knowledge in QA, and / or manufacturing.
35. Knowledge of Lean Manufacturing and/or Six Sigma methodology.
36. Strong, current grasp of regulatory and GMP requirements - knowledge of FDA processes specifically would be a distinct advantage.
37. Bachelor’s degree in engineering, Science or related field or proven Quality background - ideally five years’ experience in the medical or life sciences sectors.
38. 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. To help us achieve our goals, we’ll give you everything you need to help you achieve yours.
We also provide access to LinkedIn Learning to help you develop in your career and grow with CooperVision
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.