Quality Operations Team Lead

Tata Consultancy Services; Leeds; On-site; GBP 40,000 - 80,000; Full time

Benefits offered by this job

Pension

Health Care

Life Assurance

Laptop

Phone

Training Resources

Discounts within Tata Network

Job summary

An established industry player seeks a Quality Operations Team Lead to drive quality engineering efforts across manufacturing processes. This role involves leading projects for process improvements, ensuring compliance with FDA and ISO standards, and mentoring team members. The ideal candidate will have a strong technical background in manufacturing and risk management, along with expertise in Lean and Six Sigma methodologies. Join a company recognized as a top employer, where you can thrive in a culture of diversity and inclusion while making a significant impact on product quality and operational excellence.

Qualifications

• Strong understanding of FDA and ISO standards for risk management.
• Experience with Lean and Six Sigma methodologies is essential.

Responsibilities

• Lead Quality Engineering efforts for all manufacturing processes.
• Ensure compliance with FDA QSR’s and ISO 13485 requirements.
• Develop and utilize DFMEA/PFMEA for risk analysis.

Skills

Manufacturing Equipment Understanding

Product/Process Risk Management

Statistics

Lean Methodologies

Six Sigma Methodologies

Problem Solving

Project Management

Leadership Skills

Tools

Statistical Software Packages

Job description

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UK&I Technical Recruiter at Tata Consultancy Services

Role: Quality Operations Team Lead

Job Type: Permanent

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

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.
• 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.
• Develop and utilize DFMEA/PFMEA and other QA risk analysis techniques to minimize potential risk during development/implementation activity.
• Partner with Supplier Quality, Technical Support, Design QE and Purchasing to ensure that all Supplier generated products and components are compliant.
• Ensure compliance with all Documented Quality system, FDA QSR’s 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.
• 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.
• 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.
• 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.

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.

If you are an applicant who needs any adjustments to the application process or interview, please contact us at [e-mail] with the subject line: “Adjustment Request” or call TCS London Office 02031552100 to request an adjustment.

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.