Our client, a medical device company in Cork are currently looking to recruit a Senior Quality Systems Engineer for their site.
The Senior Quality Systems Engineer will plan, conduct and direct QA elements of Materials Development engineering projects or studies including completing projects in the Materials and coating areas. They will apply comprehensive and diverse knowledge of engineering principles and practices within broad assignment areas.
The Senior Quality Engineer will utilize Quality Engineering tools and practices for the effective and efficient development, transfer and maintenance of processes throughout the process/ asset lifecycle. The job holder will also utilize Quality Engineering principles and problem solving skills to improve and maintain products/processes that are aligned with the overall Quality and Business vision. He/she will utilize appropriate risk management to prevent unanticipated failure modes and improve capability of processes. This person will support processes in the cluster Materials Development group with particular responsibility for automated coating processes. The Senior Quality Engineer will also support Laboratory activities associated with Materials Development projects.
Key Responsibilities & Duties:
? Conduct benchmarking to develop more effective methods for improving quality.
? Supports the development of quality engineering and quality compliance with the right skill sets for new process introductions, and asset life cycle management.
? Review/analyze whether current product and processes (including actions or decisions conducted) are in compliance 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.
? Partner with Materials Development and other cross functional partners to ensure the proper application of process controls, risk management and the investigation/correction of test failures/challenges.
? 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.
? Development of project / process Validation strategy and Master Validation Plan.
? Review User Requirements, Functional/ Design Specifications and Design Qualification documents.
? Review and approve IQ, OQ, PQ, Test Method Validation or Software Validation documentation including deviation resolution.
? 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.
? 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..
? 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.
Education, Experience and skills
? A minimum of a Bachelor?s Degree, preferably in Engineering or related technical field.
? 4-6 years related experience within Regulated Industry.
? In-depth knowledge and experience of 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.
? Troubleshooting and problem solving.
? Good technical understanding of manufacturing equipment and processes.
? Proven ability to successfully develop new processes and technologies
? In-depth knowledge and experience Equipment Qualification and Process Validation.
? Demonstrated project management and project leadership abilities.
? Relevant experience working in manufacturing/operations, coatings experience is preferred.
? Strong knowledge of statistical software packages, preferably Minitab, with the ability to preview, graph and analyze data and be able to present data that facilitates/drives decision making.
? Understanding of the NPI (New Product Introduction) process.
May require up to 10% travel
For further information on this Senior Quality Systems Engineer role in Cork please contact Cliona O?Malley on 091730022 / firstname.lastname@example.org
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