Staff Quality Engineer

Job description

QA Staff Engineer, DePuy Synthes
Beeston, Leeds, United Kingdom

DePuy Synthes, a member of Johnson & Johnson's Family of Companies, is investing in early stage research and insights to build our long-term pipeline and enable us to implement innovative disease and care pathways on behalf of customers and the patients we all serve. As this investment includes attracting top talent, DePuy Synthes Quality department is recruiting for a Staff QA Engineer

What you're great at

You have a strong technical background with an ability to plan, direct, and conduct projects of major scope and significance to the Company with technical responsibility for, organizing, executing and coordinating assignments. You will have a passion to develop and mentor more junior staff.

You will be a good communicator who is able to make data based decisions and be able to simplify complex issues to various audiences across multiple functions. You will use Quality Engineering principles and problem-solving skills to improve and maintain develop products/processes that are aligned with the overall Quality and Business vision.

Ensuring effective risk management to prevent unanticipated failure modes and improve capability of processes.

Responsibilities will include:

You will support processes in Base Business and supervise, lead and mentor other engineers and technicians across multiple sites and/or various geographic regions.

Business Improvements
• Support quality improvement initiatives such as process and product characterizations that lead to continuous / cost improvements.
• Review/analyze 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/analyze whether current product and processes (including actions or decisions conducted) comply to 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.

Product Quality, Control & Disposition and Performance Standards
• Lead and maintain 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

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.
• 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.

Desired profile

Qualifications :

BE VITAL
You will be an experienced technical leader who has strong quality background. Ideally you will have experience of working within medical devices or another regulatory environment.

You will have a flexible approach teamed with strong influencing skills. Excellent communication skills are essential to this position.

Together with:
• 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.
• Advanced 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 be able to 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 providing sound judgment is high desired.
• Excellent 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.

What you'll own and how you'll grow:


Within DePuy Synthes we are always looking for future leaders so this position will give you great visibility to showcase your talents and develop your career. We will support you to develop both technically and personally.

You will be a critical part of the functional team and link closely with Ireland to continue to drive continuous improvement. There is a real opportunity to develop the team to deliver critical projects.

If you are ready for your career to excel to the next level then this is one in a life time chance to join the world's leading health care provider.

What we're about:

We are passionate about our work, and play vital roles across a range of professional disciplines, and care deeply about our customers and communities. At Johnson & Johnson our culture enables dynamic and impactful careers. We share a kind of DNA where we're each

• Committed to caring
• Responsible to our communities
• Ready to apply our knowledge and know-how
• Unique in our background and experiences
• The drivers of our own success
• Passionate about doing what's right

Make a unique mark in your career


Closing Date: 10th September 2018