Quality Operations Team Lead

Avance Consulting; Leeds; On-site; GBP 50,000 - 70,000; Full time

Job summary

A leading company in quality operations is seeking a Quality Operations Team Lead to manage day-to-day Quality Engineering efforts across manufacturing processes. This role demands expertise in process improvements, compliance, and risk management. The ideal candidate will have strong leadership skills, in-depth knowledge of FDA and ISO regulations, and a solid background in statistics and quality methodologies.

Qualifications

• Good technical understanding of manufacturing equipment and processes.
• In-depth knowledge of product/process Risk Management (FDA and ISO standards).
• Technical training using Statistics, Lean, and Six Sigma Methodologies is a must.

Responsibilities

• Lead Quality Engineering efforts for manufacturing processes.
• Ensure compliance with FDA QSRs and ISO 13485 requirements.
• Oversee New Product Introduction and process validation activities.

Skills

Risk Management

Lean

Six Sigma

Statistics

Problem Solving

Project Management

Leadership

Job description

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.

* Free services are subject to limitations