Quality Engineer

Job Ref: J23436
Sector: Engineering
Sub-sector: Medical Devices
Date Added: 01 September 2017
  • Chelmsford, Essex, England, UK
  • £30,000 - £40,000 per Annum
  • Laith Mustafa
  • 0161 868 2231

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Quality Engineer - Essex - Medical DeviceOverall PurposeTo support the Quality Manager by working in support of, and owning actions, as deemed necessary by the Quality Manager in promoting and driving the operational business, the QMS compliance and also by taking direct ownership of the quality role in projects, in CAPAs and in changes, collaborating closely with development and suppliers. Key TasksLead and assist the planning, implementation, documentation, monitoring and or improvement of QMS processes over the entire product life cycleUpon qualification and experience, managing and maintaining quality tools for tracking issues, improvements, training, documentation and the like. Assure and if required, improve addressed QMS processes for compliance with, ISO 13485, MDD and QSR 21 CFR 820 Establish and monitor control of manufacturing processes performed by suppliers, including inspection method transfer  Lead or assist projects, CAPAs or changes in the QMS and in supplied processes Lead or assist thorough and methodical root cause investigation of issues (NCR)  Support and review the establishing of technical documentation, including risk management, design and process verification and validation Participate in Engineering Change Requests Internal audits/external audits Documentation control  Assure the management of addressed quality tools, including CSV if applicableKnowledge, Skills and Experience Essential* Must have experience in working with regulations and international standards such as ISO 13485:2003, ISO14971, Medical device directive and 21 CFR Part 820 quality system requirements * Must have experience in the validation of manufacturing processes and auditing of such processes* Must be a hands on individual with an eye for data analysis and quality mind set for getting things right at first time and thriving to make continual improvement* Must have energy, enthusiasm, drive and a "can do" attitude * Attention to detail, analytical and methodical approach to problem solving, excellent document control * Must be extremely organised in order to prioritise multi tasks and execute them within the time* Must be able to work on own initiative as well as work within a team* Capable of handling a diverse range of projects simultaneously * Ability to achieve personal deadlines and contribute to team objectives* Must have excellent I.T. skills to maintain various databases and present quality data in the form of departmental reports * Excellent oral, written and report writing skills to all levelsFor more information, please call Laith Mustafa on 0161 868 2231 or email

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.