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If you need support in completing the application or if you require a different format of this document, please get in touch with at UKI.recruitmenttcs.com or call TCS London Office number 02031552100 with the subject line: Application Support Request. Role: Quality Operations Team Lead Job Type: Permanent Location: Leeds, UK (Onsite) Number of hours: 40 hours per week full time Ready to utilize your experience and expertise in the use of quality Engineering tools and practices for the effective and efficient development? We have an exciting role for you Quality Operations Team Lead Careers at TCS: It means more TCS is a purpose-led transformation company, built on belief. We do not just help businesses to transform through technology. We support them in making a meaningful difference to the people and communities they serve - our clients include some of the biggest brands in the UK and worldwide. For you, it means more to make an impact that matters, through challenging projects which demand ambitious innovation and thought leadership. Build strong relationships with a diverse range of stakeholders. Gain access to endless learning opportunities. Work closely with the range of teams within the business to bring products to life. The Role As a Quality Operations Team Lead, you will be accountable for the day-to-day Quality Engineering effort for all manufacturing processes. This will include managing projects designed to identify and implement process improvements within the area, validation and receiving inspection area. You will utilize Quality Engineering tools and practices for the effective and efficient development, transfer and maintenance of products/processes throughout the product lifecycle. Key responsibilities: Lead Quality Engineering effort for all manufacturing processes. This will include managing projects designed to identify and implement process improvements within the area. Lead Receiving Inspection function, ensuring efficient and compliant processes are deployed. Lead the quality activities for all product and process validation activities for client. Develop and maintain state of the art protocols and procedures and ensure correct implementation across site. Provide technical expertise for all areas on relevant IQ/OQ/PQ protocol issues. Lead site wide activities aimed at maintaining Part 11 Compliance. Assess the need for risk mitigation techniques based on product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls, etc. Determine effectiveness of these techniques on previously implemented improvements. Support the quality effort for all New Product Introduction activities to ensure that all quality aspects of process design are addressed. Document and maintain in good order all relevant sections of Device Design History File and DMR as directed. Develop and utilize DFMEA/PFMEA and other QA risk analysis techniques to minimize potential risk during development/implementation activity. Work with Production and Technical Support to develop and implement appropriate process control plans. Partner with Supplier Quality, Technical Support, Design QE and Purchasing to ensure that all Supplier generated products and components are compliant. Partner with Supplier Quality, Technical Support, Design QE and Purchasing to ensure that all Supplier generated design changes are managed and documented in a compliant manner. Ensure compliance with all Documented Quality system, FDA QSRs and ISO 13485 requirements during day to day and assigned audit/CAPA activities. Maintain a good level of housekeeping in designated areas and observe all Health and Safety at work requirements. Operate within the companys standard procedures where applicable, and review, maintain and create appropriate procedures for sphere of activity. Responsible for communicating business-related issues or opportunities to next management level For those who supervise or manage a staff, they are responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures. Your Profile Essential skills/knowledge/experience: Good technical understanding of manufacturing equipment and processes is required. In-depth knowledge and experience of product/process Risk Management (FDA and ISO standards). Technical training and experience using Statistics, Lean and Six Sigma Methodologies is required including Measurement System Analysis, SPC, DOEs, Reliability, etc. Strong knowledge of statistical software packages is preferred with the ability to review, analyze and present data that drives decision making. The ability to perform "hands on" troubleshooting and problem solving is required. The ability to think on the feet and provide sound judgment is highly desired. Understanding of the NPI (New Product Introduction) process and Process Validation is preferred. A thorough understanding of GMP/ISO regulations and validation regulations is preferred. Strong mentoring, coaching and leadership skills are required. Demonstrated project management and project leadership abilities. Rewards & Benefits TCS is consistently voted a Top Employer in the UK and globally. Our competitive salary packages feature pension, health care, life assurance, laptop, phone, access to extensive training resources and discounts within the larger Tata network. Diversity, Inclusion and Wellbeing Tata Consultancy Services UK&I is committed to meeting the accessibility needs of all individuals in accordance with the UK Equality Act 2010 and the UK Human Rights Act 1998. We believe in building and sustaining a culture of equity and belonging where everyone can thrive. Our diversity and inclusion motto is Inclusion without Exception. Our continued commitment to Culture and Diversity is reflected across our workforce implemented through equitable workplace policies and processes. Youll find a welcoming culture and many internal volunteering and social networks to join (these are optional). Our diversity, inclusion and social activities include 12 employee networks such as gender diversity, LGBTQIA & Allies, mental health, disability & neurodiversity inclusion and many more, as well as health & wellness initiatives and sports events and we sponsor the London Marathon. We welcome and embrace diversity in race, nationality, ethnicity, disability, neurodiversity, gender identity, age, physical ability, gender reassignment, sexual orientation. We are a disability inclusive employer and encourage disabled people to apply for this role. If you are an applicant who needs any adjustments to the application process or interview, please contact us at UKI.recruitmenttcs.com with the subject line: Adjustment Request or call TCS London Office 02031552100 to request an adjustment. We welcome requests prior to you completing the application and at any stage of the recruitment process. Next Steps Due to a high volume of applications, we will be unable to contact each applicant individually on the status of their application. If you have not received a direct response within 30 days, then it should be deemed unsuccessful on this occasion. Join us and do more of what matters. Apply online now.