Senior Quality Engineer

Quality Operations Team Leader

Location: Leeds 

Contract duration: 12 months 

Hours: 37

This position falls outside of IR35

Imagine your next project working in the position of a quality operations team leader where 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.

The Quality Operations Team Leader devises or adapts new methods or procedures to control or coordinate all aspects of several projects simultaneously and in the solution of technical and related projects.  

roles and responsibilities

The Quality Operations Team Leader will utilise Quality Engineering tools and practices for the effective and efficient development, transfer and maintenance of products/processes throughout the product lifecycle. The incumbent will also utilise Quality Engineering principles and problem-solving skills to improve and maintain products/processes that are aligned with the overall Quality and Business vision. You will utilise appropriate risk management to prevent unanticipated failure modes and improve capability of processes. You will support processes in base business and supervise or lead Engineers & Technicians.

This will involve

Business Improvements

• Support quality improvement initiatives such as process and product characterizations that lead to continuous / cost improvements.

• Review/analyse the effectiveness of PDCA, Six Sigma, Kaizen, Lean Techniques and/or other improvement tools and programs.

• Conduct benchmarking to develop more effective methods for improving quality

• Supports the development of quality engineering, quality compliance, quality leadership talents with the right skill sets for new product introductions, and product life cycle management. 

Compliance/Regulatory

• Review/analyse whether current product and processes (including actions or decisions conducted) comply with standards such as the QSRs, ISO 13485, etc.

• Champions compliance to applicable Global Regulations and standards (e.g. QSRs, ISO, EN and Medical Device Directive (MDD) requirements) including providing support during internal and external audits.

• Conduct periodic line audits to assess for production controls such as lot segregation.  Review results of area audits to ensure that corrective and preventive actions are adequate.

New Product/Process Introduction

• Partners with R&D and other cross functional partners to ensure the proper application of design controls, risk management and the investigation/correction of design failures/challenges.  

• Supports the development of quality strategies related to the transfer of products, materials and components within J&J or externally.  Supports new product introduction as part of design transfer.

People

• Provides supervision, mentoring, coaching, performance review, developmental plans, and succession planning for others

• Manages receiving inspection team in Leeds

Product Quality, Control & Disposition and Performance Standards

• Lead and maintain the Material Review Board.  

• Conduct investigation, bounding, documentation, review and approval of non-conformances, CAPAs and customer complaints.  Escalation of quality issues as appropriate.

• Accountability and ownership for material identification, material segregation, classification of defect types including the successful application of these techniques on a day-to-day basis in manufacturing.  

• Analyze/review effectiveness of preventive and corrective actions.  Review root cause investigation according to an established process.

• Accountability and ownership of Quality metrics including maintenance and reviewing of leading and lagging indicators of quality

Product/Process Qualification

• Approve IQ, OQ, PQ, TMV or Software Validation

Production/Process Controls including Control Plans

• Partners with J&J Global Supply chain, Finished Goods and material suppliers to ensure appropriate application of process validation, process control, and risk management; and the investigation/correction of process failures when needed.

• Conduct stakeholder analysis to ensure that customer CTQs are known and adequately addressed in control plan

• Develop measurement systems/capabilities, destructive tests, non-destructive tests for manufacturing processes

• Develop control plans consistent with product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls, etc.

• Develop, interpret and implement appropriate process monitoring and control methods consistent with the level of process/product risk. 

• Collect data and execute/conduct various analytical/statistical analysis and interpretation as part of process improvements and day-to-day support.  

• Develop, interpret and implement standard and non-standard sampling plans

• Assess effectiveness of measurement tools, destructive tests, non-destructive tests, measurement system analysis.  

• Accountability and ownership for sampling plans of all types including acceptability of risk given the product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls, etc. including assessing, applying and interpreting acceptance sampling standard for manufacturing data.

• Assess and interpret common versus special cause variation in manufacturing processing and determine adequacy of current process limits.

Risk Mitigation

• Document, justify, review or analyze whether a proposed change to a process will not enhance the risk level in some way beyond capability of current controls or whether change will result in potential non-compliance to a required standard such as the QSRs

• Assess the need for risk mitigation techniques given product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls, etc. Determine effectiveness of these techniques on previously implemented improvements

Strategic

• Conduct strategic planning with site leaders and Product Engineering Team.  Partnership with other functions to establish business priorities and resource allocation

• Ensures effective quality strategies are created for the validation of test methods, process and design.   

how to succeed

It's preferable to have 5 to 8 years of experience in manufacturing, specifically within the medical device industry. Nonetheless, we are open to considering candidates from other industries as long as you possess robust quality engineering expertise and leadership experience.

You will also bring

• A minimum of a Bachelor’s Degree, preferably in Engineering or related technical field. Generally, it requires 5-8 years related experience.  

• Experience working in both an FDA and European regulatory environment is preferred. 

• This position will require relevant experience working in manufacturing/operations.  

• In-depth knowledge of product/process Risk Management (FDA and ISO standards) is required.

• Experience with a proven track record of implementing appropriate risk mitigation. 

• 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 preview, graph and analyse data and can present data that facilitates/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 judgement is highly desired. 

• Good technical understanding of manufacturing equipment and processes is required. 

• Understanding of the NPI (New Product Introduction) process and Process Validation expertise is preferred. 

• A thorough understanding of GMP/ISO regulations and validation regulations is preferred. 

• Strong mentoring, coaching and leadership skills are required. 

• Advanced knowledge and proven leadership in the areas listed in the Duties and Responsibilities associated with the position.

• Demonstrated project management and project leadership abilities are required.  

Benefits

This role offers a very competitive hourly rate. This contract will run for 12 months and has a high chance of extension. 

you are welcome here

Johnson & Johnson is working to create an inclusive environment where diverse backgrounds, perspectives, and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are.

About Depuy Synthes 

Depuy Synthes is part of Johnson & Johnson, the largest, most innovative and comprehensive orthopaedic and neurological business in the world. Depuy Synthes offer an unparalleled breadth and depth of products, services and programs in the areas of joint reconstruction, trauma, spine, sports medicine, neurological, craniomaxillofacial, power tools and biomaterials.

Orthopaedics is the largest commercial business unit within Depuy Synthes, operating across the spectrum of joint reconstruction, trauma, sports medicine, power tools and biomaterials. We're proud to offer one of the strongest and broadest orthopaedics portfolios in the world.

application process

We are looking to process the first round of applications within the next 2 working days.

We do not accept applications via email. The pay rate for this role will depend on how you are paid. PAYE & Umbrella options are available. 

Diversity, Equity & Inclusion

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.

We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences. That is why we are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each one of our people feels that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”.