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Quality Assurance Engineer : Elekta

Employer
Manor Royal Business District
Location
Crawley, West Sussex
Salary
Competitive
Closing date
9 Oct 2020

View more

Sector
Healthcare, Manufacturing, Engineering
Function
Engineer
Contract Type
Permanent
Hours
Full Time

Job Details

Elekta

Description 

Responsible for supporting process owners in defining and implementing processes and system changes analyzing process improvements to drive efficiencies. Support the local quality management system and processes. Is an advocate of Quality and promotes the group’s vision and mission while supporting the goals of the overall business. They work closely with functional teams in areas such as Engineering, Order fulfillment, Regulatory Affairs, Sales & Marketing, and Manufacturing among others.

Responsibilities 

  • Work on projects / compliance activities to completion.
  • Prepare monthly metrics for their area of expertise / responsibility.
  • Analyze process data and trends and drives optimization / improvement.
  • Represent QA organization in specific processes (e.g. CAPA, Order fulfillment, Manufacturing, etc.)
  • Support others in the QA organization and other functional organizations on technical aspects in order to drive results.
  • Participate in external audits before regulatory authorities.
  • Participate in the execution of the internal audit plan.
  • Promote and maintain adherence to Elekta values.

Authorities 

  • Preparation of audit plans, execution of audits and preparation of audit reports as applicable. 
  • Issuing and supporting closure of non-compliances. 
  • Support processes and procedural changes. 
  • Authorize documents and forms.

Relevant Knowledge, skills and competEncies 

  • Bachelor’s degree in Engineering, Software Engineering or Quality Engineering, or a related field or a formal engineering apprenticeship with demonstrated experience in a similar role
  • Training and experience in relevant medical device regulatory requirements and standards (e.g. ISO13485, ISO14971, ISO 63304, IEC, MDR, QSR, CMDR.)
  • Proven experience in relevant areas of Quality, Regulatory, Software Engineering or Engineering, preferably within a medical device environment.
  • Strong written and verbal communication skills and ability to collaborate effectively.
  • Objective driven and customer focused. Capable of producing results working unsupervised under own initiative.
  • Professional integrity. Able to translate regulations into meaningful business requirements.
  • Possess a structured approach to problem solving with an appreciation of quality tools & techniques. 
  • Must be an effective team player with the ability to mentor, lead and problem solve to provide solutions to the business.
  • Confident and open personality who is able to communicate effectively, both written and orally with people at all levels. 
  • Ability to work efficiently under tight timelines.
  • Proven fluency in English and other applicable languages relevant to their specific geographies.
  • Quality professional certifications preferred (e.g. CQI, CQMoE, CQA, CQE.)
  • Experience in quality improvement tools and techniques is a plus (e.g. Lean, Six Sigma, DOE, Statistical Methods, etc.)
  • Travel may be required.

Company

Manor Royal Business District is the biggest business park of the Gatwick Diamond area and one of the south east's premier mixed activity employment hubs.

Enviable location and connections

Situated at the heart of the Gatwick Diamond on the Sussex and Surrey county borders, just two miles from London Gatwick Airport, a major motorway junction (M23 Junctoion 10) and two mainline railway stations (Gatwick Airport and Three Bridges), Manor Royal is a popular choice for a diverse range of occupiers including a host of blue chip global brands.

Manor Royal in numbers

  • One of the biggest business parks in the South East.
  • Covers an area of 539 acres – that’s over 300 football pitches.
  • 700 properties
  • 500 businesses
  • 30,000 people

Manor Royal more than a number

Since the formation of the Manor Royal Business Group (MRBG), an association of Manor Royal based business and firms, being on Manor Royal means being part of something. You’re never just a number.

Manor Royal makes sense

Scale, diversity, location and great connectivity with a property offer to match means Manor Royal based firms are never far away from their suppliers, customers and a talented workforce.

Pay us a visit

Visit www.manorroyal.org to find out more and to get in touch

 

Company info
Website
Mini-site
Manor Royal Business District
Location
7 Magellan Terrace (Ground Floor)
Gatwick Road
Crawley
West Sussex
RH10 9PJ
United Kingdom

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