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Quality Systems Engineer (Contract) - Southern

Medical/Pharmaceutical - Quality
Ref: 143 Date Posted: Monday 20 Nov 2017
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Quality Systems Engineer (Contract)                                     Location: Southend on Sea, UK

A fantastic chance to project lead QMS (Quality Management Systems) and update ISO for a market leading firm


Do you possess an unprecedented eye for detail and the ability to deliver and maintain unrivalled quality? Are you the ultimate perfectionist? Is your focus on leading a project and delivering exemplary results for a market leading firm? Fancy a short spell at the seaside? If it’s an almighty yes to all the above then please read on as this could well be the opportunity you have been searching for.


The Opportunity


As the Quality Systems Engineer, you will be the driving force in updating compliance procedures and processes throughout the QMS. Reporting to the Head of QARA (Quality Assurance and Regulatory Affairs), you will be utilising your extensive problem-solving skills to ensure complex quality systems compliance projects are completed, driving the business forward. Think along the lines of QMS certification and product registrations and you’re on the right track.


Alongside the Project Manager, you will play a key role in leading and managing cross-functional project teams whilst participating in MDSAP (Medical Device Single Audit Program), ISO9001:2015 and ISO13485:2016 projects and conducting relevant activities across the organisation to ensure the achievement of ISO9001:2015 and ISO13485:2016 certification. You will primarily be working under minimal supervision throughout the ISO transition, so if you thrive in an independent working environment then this is the role for you.


As part of your role (but not limited to), you will be working closely with management teams and process owners lending your expertise to provide process management experience and translate specific ISO requirements to the relevant personnel, ensuring your delivery is always on time. You will be a key focal point in supporting process owners to define relevant process monitoring and measurement requirements, whilst also making sure the customers’ requirements are achieved and improved.


Flexing your organisational skills and expert time management should be second nature. You will not be afraid to ask those difficult and challenging questions where required. Aside from being a razor-sharp individual, you will be able to use your own initiative, but also willing to work as part of a team. The role does require a bit of travelling and the odd late night but there is a major airport nearby, as well as all the usual public transport routes throughout the area if you need to commute.


Desirable Skills and Abilities


The ideal candidate then will possess the ability to communicate confidently, clearly and to be concise at all times. You should be able to present information in a balanced and structured manner. Your analytical skills will be unrivalled with the ability to visualise, articulate, conceptualise and solve both simple and complex issues. Finally, you will have the resilience of a rock and the people management skills of a saint when dealing with potentially confrontational or difficult situations.


Experience and Qualifications


  • Minimum 3 years’ experience in a Quality or related field
  • Previous experience of ISO9001 (2008/2015) and ISO13485 (2003/2012/2016)
  • Good working knowledge of Microsoft Office
  • Lead Six Sigma Yellow Belt above is highly desired
  • 1st Degree in scientific or engineering related discipline
  • Certified Lead Auditor Qualification for ISO13485 and ISO9001 is highly desired
  • Previous participation in Quality Improvement Project and any demonstrated Project Delivery would be highly desired


Our client is a global Medical Device company with multiple facilities in the UK, across Europe, The USA and Asia. Producing world class products in terms of quality, cost and delivery isn't just desirable, it's essential. Therefore, in today's fast moving, ever changing world, they continue to invest in both their people and the latest equipment and processes to remain at the forefront in manufacturing technology.


The Next Step


Medical Engineers welcomes enquiries from all quality management backgrounds relating to science and engineering within medical technology and other highly regulated industries. Regardless of your current team size and structure, we will treat all communication in strict confidence.


Calls can be arranged outside office hours, please let us know in your communication and we will get this arrange in a time to suit you.


Contact: Jonathan Sleight

Direct: 0161 2600 193


Specialists in consultancy

At Medical Engineers we have a range of technical consulting jobs in the medical engineering industry throughout the UK. Requiring a broad range of technical and management skills and most importantly the ability to communicate effectively. Consultancy roles require candidates with unique abilities. Roles vary in length of contract depending on clients’ requirements.

Our degree qualified consultants have specialist knowledge of the UK medical engineering consultancy job market. We have a successful track record in finding the best candidates for our clients who know and trust Medical Engineers to understand their business requirements.

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