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Software Quality Assurance Engineer m/f Walluf Germany,  

PerkinElmer (company)


Posted on : 26 February 2017

Project Description


 Job Description : 
  • Company compliance expert to ensure computerized system and software used as a medical device, used in medical device application, or used in regulated environment complies with industry practices and comply with internal requirements, applicable external standards and regulations.
  • Provide expertise in applicable industry standards and regulations including, but not limited to as IEC 62304, FDA guidance, FDA Part 11, ISO13485, ISO14971, IEC 62366-1
  • Review, support, and improve all phases of the Software Development Life Cycle (SDLC) documentation (e.g. requirements, architecture, verification, validation, test, etc.).
  •  Provide guidance and expertise on all software development procedures and practices.
  •  Actively participate as QA representative in software team meetings (e.g. code review, risk analysis, etc.).
  •  Actively participate in Risk Analysis discussions with the product development team(s).
  •  Provide independent review to the software development and test team(s)
  •  Provide guidance in the development of specific tests and testing methodologies to the software test team. 
  •  Provide cross functional support to other Quality Department functions, including other sites within company Medical Imaging 
 

Job Requirements : 
  • University degree Computer Science or equivalent experience required 
  • Five or more years  experience working as a software QA Engineer in a medical device regulated organization required
  • Direct work experience with medical device software related standards and regulations such as IEC 62304, FDA guidance, FDA Part 11, ISO13485, ISO14971, IEC 62366-1 required
  • In-depth knowledge on Software Quality Assurance Engineering fundamentals required
  • Experience in designing software testing strategies required
  • Working knowledge of C++/C/C# programming languages required
  • Knowledge of additional programming languages is preferred 
  • Experience with defect, test and configuration management tools (e.g., JIRA, DOORS, Polarion, Microsoft TFS, etc.).
  • Strong time management skills and ability to prioritize
  • Requires flexible work schedule and support of international company business time zones, and locations 
  • Working knowledge of Quality System Requirements to meet ISO 13485, MDD, and FDA QSR required
  • Experienced in handling external audits preferred
  • Experience with FDA inspections is desired.
  • Qualified internal auditor for ISO 13485 and or FDA QSR desired 
  •  Fluent in German and English (written and spoken) 


Locations

Walluf Hessen DE

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