GE Healthcare
Lead - Quality Assurance Engineer

  • Budapest, Helsinki, Finland, Hungary
  • Fulltime
  • Advanced
  • Job details
  • Job details
  • Job details
  • Job details
  • Job details

Role Summary/Purpose

This Lead Quality Assurance Engineer position is the subject matter expert focused on software quality & compliance to the Quality Management System (QMS). He/she ensures each project meets or exceeds customer expectations and global regulatory requirements related to software. This is a key technical and leadership role that works closely with product management & engineering to ensure successful design, development, testing & release of the product.

Essential Responsibilities

  • Ensures program deliverables comply to the business imperatives, Quality Management System and applicable global standards.  
  • Leads, acknowledges, develops, communicates & implements a strategy to ensure compliance.  
  • Drives continuous improvement activities focused on development processes or products.  
  • Reviews & evaluates trends of software defects and recommends improvement actions. 
  • Leads cross-functional product risk management activities. 
  • Collaborates with cross-functional program teams to ensure timely release of products.  
  • Leads programs and initiatives, and has responsibility for coaching other SWQE’s.
  • Qualifications/Requirements

  • Bachelor's Degree in Computer Science, Engineering or similar technical discipline or strong relevant work experience. (or a Masters degree in Computer Science, Engineering or similar technical discipline in lieu of relevant work experience.) 
  • Relevant work experience working in a regulated industry. 
  • Ability to communicate effectively in English (both written and oral).  
  • Demonstrated experience and proficiency with MS Office word processing, spreadsheet, presentation, and database applications.
  • Desired Characteristics

  • Strong software development experience in a regulated industry.  
  • Understanding of product software development lifecycles, software design change and document change control, software process verification and validation methodologies, and servicing in a medical device environment.  
  • Understanding Medical Device QMS requirements including but not limited to FDA 21 CFR 820, EN 62304 and ISO 13485.  
  • Expertise mentoring the organization in software design controls, Corrective & Preventive Action (CAPA), complaints, risk management & product quality improvement. 
  • Demonstrated collaboration, negotiation & conflict resolution skills 
  • Excellent communication skills (written and oral)  
  • Demonstrated ability to lead, acknowledge, develop, communicate & implement a strategy under crisis situations to ensure compliance  
  • Demonstrated understanding of continuous quality / process improvement tools: (As defined by the local site, e.g. DMIAC, SPC, Lean SS, 5S)  
  • Change agent with energy, passion & enthusiasm to drive change. 
  • Experience performing internal audits and participating in external audits 
  • Exceptional analytical, problem solving & root-cause analysis skills 
  • Ability to multi-task & handle tasks with competing priorities effectively  
  • Strong technical aptitude (i.e. able to read & comprehend technical documentation & execute procedures), global regulatory experience & demonstrated experience interfacing with regulators.
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