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Ark Talent Group Limited
,
Wakefield, West Yorkshire
Design Quality Engineer
Overview
Our client is looking for an experienced engineer working in manufacturing/operations as well as FDA and European regulatory environment. Overview: · Conduct assignments encompassing complete projects or portions of major projects. · Determine methods and techniques to be used or adapt standard methods to meet variations. · Coordinate phases of work internally and externally. · Utilize Quality Engineering tools and practices for the effective and efficient development, transfer and maintenance of products/processes throughout the product lifecycle. · Utilize Quality Engineering principles and problem-solving skills to improve and maintain products/processes that are aligned with the overall Quality and Business vision. · Utilize appropriate risk management to prevent unanticipated failure modes and improve capability of processes. Responsibilities & Duties: • Review/analyse the effectiveness of PDCA, Six Sigma, Kaizen, Lean Techniques and/or other improvement tools and programs. • Review/analyse 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. • 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 new product introduction as part of design transfer. • Supports activities related to the Material Review Board. • Conduct investigation, bounding, documentation, review and approval of non-conformances, CAPAs and customer complaints. Escalation of quality issues as appropriate. • Approve IQ, OQ, PQ, TMV or Software Validation • To ensure appropriate application of process validation, process control, and risk management; and the investigation/correction of process failures when needed. • Develop, interpret and implement appropriate process monitoring and control methods consistent with the level of process/product risk. • Document, justify, review or analyse 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 • Ensures effective quality strategies are created for the validation of test methods, process and design. Requirements: • 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 is preferred 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. • Understanding of the NPI (New Product Introduction) process and Process Validation expertise. • A thorough understanding of GMP/ISO regulations and validation regulations. • Demonstrated project management and project leadership abilities. Please apply online or contact Crina Banarescu at Ark Talent Group for further information. This job was originally posted as www.totaljobs.com/job/89707193