DESIGN QUALITY ENGINEER - SOUTHAMPTON - PERMANENT - MEDICAL DEVICES
SRG are working with a hugely successful and rewarding Medical Device organisation who can offer a long lasting and rewarding career path. This is a permanent position ideal for someone with a minimum of 18 months experience within Quality systems and Design documentation - within a Medical Device setting.
Overview of Role:Assisting OR Leading Concept Research Control or Design Control activities, and Risk Management in the R&D and Manufacturing (depending on level of experience). Essential Functions: * Maintain and update global procedures for Design Control and Risk Management that adheres to FDA CFR21 Part 820, ISO 13485, and ISO 14971.* Lead and review Concept Research Control or Design Control activities for clinical trial sample production, new products or process development, during all control phases, including design reviews, design, design change, design history files, etc.* Develop and/or review of clinical trial sample/product/process development documentation, test method validation documentation, software/computer system validation documentation and process validation documentation.* Support company goals and objectives, policies and procedures in compliance with quality manual and quality system processes such as; CAPA system, Change Control, Management Review, Complaints, and Audits Knowledge and Skills:* GMP experience mandatory. GLP, or GCP, experience ideal.* Applied technical knowledge of Qualitative and Quantitative data analysis, and statistical tools. Six Sigma Green Belt qualified or CQE ideal. If interested and qualified to carry out this role please send an updated CV or call 0171 868 2236 for more information.
The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.