Design Quality Engineer

Job Ref: J28174
Sector: Engineering
Sub-sector: Medical Devices
Job Type: Permanent
Date Added: 23 August 2018
  • Cheshire, England, UK
  • £30,000 - £50,000 per Annum
  • Laith Mustafa
  • 0161 868 2231

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Design Quality Engineer - Medical Devices - Cheshire - £CompetitiveSRG are currently recruiting for a Design Quality Engineer to join a Global Medical Device comapny in Cheshire on a permanent basis at a competitive salary and benefits package, depending on experience.Reporting to the Quality Manager you will be responsible for;* Standardising the design control and risk management process * Supporting the Quality, R&D and New Product Development (NPD) processes to deliver high quality and innovative medical device launches on time.* Working with R&D, Regulatory Affairs, Operations, Business Unit and Quality teams to:* Supporting new product development and launch activities from formal development stage through to transfer into manufacturing.* Supporting creation of robust Design History Files and Regulatory Files.* Supporting pre-launch risk management activities ensuring robust product and process design.* Supporting the development of robust product specifications, sampling plans and control plans.* Identifying and implementing continuous improvement initiatives.Knowledge & Skills* Requires degree level in STEM subject or equivalent industry experience.* Previous experience in new product design or quality engineering (Medical Device experience required) and risk management.* Working knowledge of and experience in developing products in a regulated environment and to the requirements of cGMP, CFR 21 Part 820, MDD 93/42/EEC and ISO 13485.* Will have a fundamental understanding of a quality management system and its development, documentation and implementation.* Will have strong understanding and experience of Design Control and New Product Development processes.* Will have strong understanding and experience of risk management, risk assessment tools and techniques and reporting in accordance with ISO 14971.* Will have working knowledge of new product regulatory requirements and approval processes.* Certified Six Sigma Green or Black Belt (desirable), or have strong understanding of statistical tools and techniques.* Experience in review of product and process validation deliverables (essential).* Experience in medical device sterilization (desirable).* Certified Quality Auditor or Lead Auditor (desirable).* Able to demonstrate achievement and continual improvement against key performance targets and Quality Objectives (essential).* Knowledge of and experience in root cause analysis, problem-solving, and quality improvement tools and techniques (essential).* Able to manage own time effectively, prioritise tasks and deliver to critical deadlines (essential).* Excellent communication skills; written, verbal and presenting (essential).* Able to work autonomously and as part of a multi-disciplinary team.* Keen attention to detail.* Flexible and adaptable to changing work environment.* Must be computer literate eg. Microsoft Word, Excel, PowerPoint, Project, Lotus Notes, ERP systems.For 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.

22/09/2018 15:32:27
GBP 30000 30000.