Quality Engineer

May 3, 2022 /

The Quality Engineer will be a member of the Quality team and will support maintenance of the Quality System, ensuring compliance to Customer, Regulatory and Quality System Requirements. The activities will include, but are not limited to, maintaining quality system metrics, supporting validation, production and risk management activities. 

 The Quality Engineer will handle multiple projects and tasks, from product inception through to production, utilising a high level of written and oral communication skills. 

 The Quality Engineer will be working as part of a team to maintain high quality / performance standards across multiple production lines, from receiving inspection to final release, including but not limited to validation, testing, and continuous monitoring of product/process performance. 

 The Quality Engineer will play an active role in the processes to ensure products meet quality and compliance standards regulations while meeting all design controls, risk management, change control requirements and other applicable regulatory requirements. 

 

Roles & Responsibilities

  • Ability to manage and control multiple activities. Excellent attention to detail & organisation skills required. 
  • Works closely with product development engineering and the client team to establish the product specifications and product specific requirements. 
  • Perform an active role in quality planning and new product introduction from a QA perspective. 
  • Compile and report quality metrics. 
  • Support regulatory, internal and customer audits. 
  • Support equipment and process validation activities including generation / updates to MVP.  
  • Ensure compliance across projects for design control, risk management, and change control processes. 
  • Manage quality engineering activities from receiving to final release, including but not limited to validation, testing, and continuous monitoring of product/process performance using applicable sampling and statistical techniques. 
  • Support Quality culture within the organisation while providing training and guidance on applicable requirements / standards. 
  • Provides manufacturing line support and provide Quality expertise in relation to Manufacturing issues and product disposition. 
  • Have a good working knowledge of applicable medical device / testing standards. 
  • Deals with suppliers and ensures their quality standards are in line with company standards. 
  • Induction Training, GMP and GDP Training. 
  • Supporting / Reviewing Change Control. 
  • Perform other related duties as required. 

 

Requirements

  • Degree in Quality or Degree in Science / Engineering. 
  • Experience within a similar role as quality engineer would be an advantage. 
  • 3+yrs industry experience in a medical device-manufacturing or pharmaceutical environment. 
  • Working knowledge of FDA and ISO Quality systems for Medical device companies. 
  • New product introduction and manufacturing process transfer experience would be an advantage. 
  • Quality experience in component and device manufacturing desirable. 
  • Proficient in MiniTab (or equivalent statistical software) and Microsoft Office applications e.g. Outlook, Word, Excel, Visio, PowerPoint, and Teams. 
  • Strong interpersonal skills and the ability to communicate appropriately with different engineering teams, management, vendors and customers.  
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Quality Engineer


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