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Senior Quality Engineer - Plymouth - Devon - Southern

Competitive salary & fantastic benefits - Quality
Ref: 167 Date Posted: Monday 05 Mar 2018
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Senior Quality Engineer - Plymouth - Devon

Our client is a globally recognised manufacturer and supplier to the aerospace, automotive, medical and industrial sectors. With over 40 years’ experience in manufacturing tools, injection moulding, thermoforming, finishing and assembly, they offer a complete service in engineering polymers at their purpose-designed 4000 square metre factory based in the South West. With a constant eye on the future, our client is dedicated to investing in state-of-the-art integrated business management systems to serve the needs of its customers to the highest level possible.


The Opportunity


We’re on the hunt for someone with a consistently fresh outlook towards continuous improvement and a desire to work in the best possible surroundings, with the best possible people. If you have a passion for unparalleled perfection and a forward-thinking personality then this could be the ideal opportunity for you.


Reporting to the Quality Manager, you will be responsible for assisting in the implementation, management, maintenance and improvement of the Quality System as a whole. This includes (but not limited to) Corrective and Preventative Action (CAPA), Auditing, Risk Management, Supplier Management, Change Management and ensuring all files and products are up to date and in line with Quality & Regulatory compliance. You will be deputising the Quality Manager as and when required if they are off-site, which includes responsibility as the Quality Management System representative and providing leadership to the QA/RA department.


As the Senior Quality System Specialist, your principal responsibilities include generation of status and trend reports and preparation of information for Management Review meetings. You will participate and lead during FDA or Notified Body audits and assist in drafting responses for external assessments where required. After completion of mandatory training, you will also be required to assist in staff training and development, assist in Supplier Management and CAPA processes, coordinate Internal Audits and ensure all complaints are dealt with in a professional and timely manner. You will provide leadership on key projects for continuous improvement on the Quality system and other business projects, giving you the chance to utilize your existing Quality experience and develop new skills along the way.


Essential Requirements


  • Comprehensive knowledge of Quality Systems standards & regulations: 21 CFR 820, ISO 9001, ISO 13485 and MDSAP
  • Minimum 2 years’ experience auditing n FDA regulated industry
  • Experience auditing high-volume manufacturing and transactional processes
  • Project Management and Leadership experience
  • Due to complex nature of QS duties, you must have excellent time management skills and be able to work under minimum supervision


Desirable Requirements


  • Experience in high-volume plastic moulding and sterile medical device manufacturing
  • Continuous Improvement
  • Problem-solving and decision-making skills
  • Ability to respond to change and deliver results 


The Next Step


Medical Engineers would invite enquiries from research and development leaders from the medical technology and other highly regulated industries, regardless of your current team size and structure we will treat all communication in strict confidence. 


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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