s degree in relevant engineering discipline. Good communication and presentation skills 5 years experience (Min) in medical devices design and development with understanding of ISO13485 and IEC 60601 design control standards Multi-disciplinary engineering background (e.g., mechanics, electronics, software, data analysis and processing) with a generalist view more »
s degree in relevant engineering discipline. Good communication and presentation skills 5 years experience (Min) in medical devices design and development with understanding of ISO13485 and IEC 60601 design control standards Multi-disciplinary engineering background (e.g., mechanics, electronics, software, data analysis and processing) with a generalist view more »
Newcastle upon Tyne, Northumberland, United Kingdom
Confidential
s degree in relevant engineering discipline. Good communication and presentation skills 5 years experience (Min) in medical devices design and development with understanding of ISO13485 and IEC 60601 design control standards Multi-disciplinary engineering background (e.g., mechanics, electronics, software, data analysis and processing) with a generalist view more »
ideally have the following attributes: Degree qualified or experience working in similar role 2-4 years experience working with highly regulated standards. IATF 16949, ISO13485 or AS9100 Structured approach to problem solving methodologies APQP/PPAP experience Certified Lead auditor Electronic assembly experience beneficial Self-motivated individual, able to set more »
to reduce or mitigate any identified risks. Maintain knowledge of site policies and procedures, especially the quality system Develop and maintain working knowledge of ISO13485 & ISO9001, MDD/MDR, GDP, ISO27001 and LSAS requirements. Support regulatory and customer audits when delegated by the QA/RA Manager/Management representative … NC, CAPAs, Change Controls, Document updates, Risk Assessments. Support the internal audits/self inspection schedule and perform audits against cGDP and standards; ISO9001, ISO13485, ISO27001, ISO22301 & LSAS as the schedule dictates and maintain an inspection ready status. Perform local area and local system audits. Training/coaching of operations … a medical device or pharmaceutical quality function Qualified Internal Auditor Desirable: Good knowledge of the requirements of the MDD/MDR as well as ISO13485 & ISO9001 Ability to work in matrix teams. Experience of working with multiple QMS systems Understanding of the requirements of GDPR & ISO27001 Basic knowledge of the more »
