- Reference: CJ43544
- Job Type: Contract
- Location: Cork, Cork city, Munster
- Category: Engineering, Technical & Manufacturing
Reports To: Quality Engineering Manager
The Senior Quality Engineer will plan, conduct and direct Quality Engineering elements of 3D Printing/ Additive Manufacturing projects or studies including completing projects and coordinating activities at the Cork site.
The Quality Process Engineer will be required to:
- Devises or adapts new methods or procedures to control or coordinate all aspects of 3D Printing/ Additive Manufacturing.
- Be the emerging authority in this specific technical field, exercising considerable latitude in determining technical objectives of assignments.
- Develop new or refined methods to reduce risk to equipment, materials, processes, products and or technical methods
- Utilize Quality Engineering tools and practices for the effective and efficient development, transfer and maintenance of Additive Manufacturing products/ processes throughout the product lifecycle.
- Utilize Quality Engineering principles and problem solving skills to improve and maintain Additive Manufacturing products/processes so that are aligned with the overall Quality and Business vision.
- Utilize appropriate risk management skills and tools to prevent unanticipated failure modes and improve capability of 3D Printing processes.
- Review and drive alignment of our Quality Management System to relevant regulations, standards, GxP requirements, and industry best practices for 3D Printing processes and products.
Major Responsibilities & Duties:
- 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/ process introductions, and product life cycle management.
- Review/analyse whether Additive Manufacturing product and processes (including actions or decisions conducted) are in compliance to standards such as the QSRs, ISO 13485, MDD and ASTM 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 Materials Development, 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 as related to Additive Manufacturing.
- Supports the development of quality strategies, where required, related to the transfer of products, materials and components within the company or externally. Supports new process introduction as part of design transfer.
- Development of project / process Validation strategy and Master Validation Plan for Additive Manufacturing.
- Review User Requirements, Functional/ Design Specifications and Design Qualification documents.
- Review and approve commissioning documents including FAT and SAT documents.
- Review and approve IQ, OQ, PQ, Test Method Validation or Software Validation documentation including deviation resolution.
Production/Process Controls including Control Plans
- Partners with the company 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 additive 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.
- 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 Additive Manufacturing processing and determine adequacy of current process limits.
- Document, justify, review or analyse whether a proposed change to a the Additive Manufacturing 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
- Conduct strategic planning with site leaders and the Additive Manufacturing company Council.
- Partner with other functions to establish business priorities and resource allocation requirements.
- Ensures effective quality strategies are created for the validation of test methods, process and design as related to Additive Manufacturing.
- Supports execution of strategic vision and plan by collaborating with other quality leaders to identify required Quality Engineering skills and requirements.
- A minimum of a Bachelor’s Degree, preferably in Engineering or related technical field.
- Requires 4-6 years related experience within regulated environment.
- In-depth knowledge of product/process Risk Management (FDA and ISO standards).
- Experience with a proven track record of implementing appropriate risk mitigation.
- Technical training and experience using Statistics, Lean and Six Sigma Methodologies including Measurement System Analysis, SPC, DOEs, Reliability, etc.
- Strong knowledge of statistical software packages is preferred with the ability to preview, graph and analyze 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 highly desired.
- Good technical understanding of manufacturing equipment and processes.
- In-depth knowledge and experience of Equipment Qualification and Process Validation.
- 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.
- Proven ability to successfully develop new processes and technologies
- Relevant experience working in 3D Printing/ Additive Manufacturing
- Relevant experience working in manufacturing/operations and introducing new processes is preferred.
For a confidential discussion and more information on the role, please contact Emer O’ Callaghan on 021 4911061 or email firstname.lastname@example.org
For more information on our Recruitment and HR Services and to see a full list of our available jobs across Ireland, please visit our website www.collinsmcnicholas.ie
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