Quality Engineer

Overview: Working alongside our client, a leading medical device manufacturer we are experienced Quality Engineer to join their team.

Benefits:

• 27 days annual leave + bank holidays
  
  
• Eligible for a 5% performance bonus
  
  
• Personal development plans available for career progression
  
  
• Salary sacrifice pension scheme
  
  
• 3x life insurance cover
  
  
• Free refreshments including tea, coffee & fresh fruit
  
  
• Free on-site parking
  
  
• Free branded workwear
  
  
• Well situated next to a train station with good transport links
  
  Remit:
  
  
• As a Quality Engineer you will support the Quality Manager and Regulatory Affairs Manager to drive continuous improvement and develop / maintain Quality throughout all stages of the product Lifecycle.
  
  
• The successful candidate will be experienced in Quality Assurance systems and processes, and able to demonstrate knowledge and experience of applying Quality Tools and Techniques, ideally within the medical device sector however regulated industry experience will be considered.
  
  Role:
  
  
• Support the companies driven Validation / Verification processes to ensure a successful and timely conclusion using the output from the process as the input into the in-process inspection criteria, sample size and frequency, etc.
  
  
• Support the Regulatory Affairs Manager to create and maintain product Technical Files in accordance with requirements.
  
  
• Maintain and improve the company's Quality Management System and internal processes.
  
  
• Lead targeted problem-solving activities to address specific problems as and when they arise during development and in production.
  
  
• Lead Change Management activities ensuring robust adherence to all processes and applicable requirements.
  
  
• Support adherence to the company’s Internal and Supplier Audit schedules and the implementation of robust actions to address and follow up on any issues raised.
  
  
• Act as an ambassador for Quality throughout all levels of the business. Help to ensure requirements are understood and participate in coaching and training activities as required.
  
  
• Other various quality-based tasks as directed by the Quality Manager.
  
  Experience Requirements:
  
  
• Knowledge of quality systems e.g., ISO9001, ISO13485, MDD/MDR, CFR Part 820 & ISO14971
  
  
• Experience of applying Quality Tools and Techniques within a relevant industry – e.g. FMEA, RCA, CAPA, 8D, APQP, 5 Why, MSA, Statistical Analysis (Minitab).
  
  
• Excellent communication skills, both written and verbal.
  
  
• Strong organisational and time management skills and ability to manage own workload independently.
  
  
• Strong attention to detail
  
  Key Words: “Quality Engineer”, “Senior Quality Engineer”, “Quality Manager”, “Senior Quality Technician”, “Medical Device” “injection moulding”, “ISO13485”, “ISO9001”,
  
  FOOTER
  
  Due to the sheer volume of applications we receive we will only contact successful applications that meet the requirements of our client job brief. Therefore, if you have not heard from us within 10 working days, please deem your application as unsuccessful.
  
  For all UK job positions work seekers must be eligible to work and live in the UK
  
  Sierra 57 Consult –
  
  Technical Engineering & Manufacturing Recruitment Specialist – Plastics, Packaging & Precision Engineering
  
  “Sierra 57 Consult Ltd are acting as an Employment Agency in relation to this vacancy. In compliance with the new regulations (April 2004) in place under the Employment Agencies Act, Sierra 57 Consult will require proof of identification. A current copy of a passport, driving license, ID card or NI card will be required as part of the registration process. Email copies are acceptable”.
  
  Sierra 57 Consult has been designed to project manage the mechanics of all aspects concerning the recruitment processes, implementing a simple and succinct method for targeting and introducing bona fide and skilled candidates to reputable clients and potential employers.
  
  If this advertised position does not interest you, please consider our other opportunities by sending your updated CV outlining your achievements and your personal requisites, i.e. salary, location, job roles. Please just Google “Sierra 57” & register with us