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Software Quality Assurance Engineer

Belgium, Vlaams Gewest, LeuvenQuality

Job description

As our Software Quality Assurance Engineer, you partner with the development team (particularly, the software team).

You will need to make sure that all the relevant design control activities are carried out to a high standard, in compliance with IEC 62304, ISO 13485 and 21 CFR 820, and support all the software development team actively to engage within the Software development process.

You will also provide expertise in automated software, particularly with respect to software used in a GMP environment.

Your responsibilities include:

  • To work with the software development teams to develop, approve execute software validation plans, risk management plan and software requirements (safety, functionality, usability) to ensure provisions for quality are addressed and conflicts are resolved prior to release.
  • Brief QA/RA management of successes and escalate concerns in a timely manner.
  • To coordinate with the development of essential software design control deliverables including, but not limited to software requirements documents, software output specifications, software design verification, software design validation, software design reviews, integration planning and testing and software release.
  • To partner with QA and RA functions including the document services team, in order to efficiently and effectively deliver necessary software quality elements in accordance with the project plan.
  • Where necessary represent the QA group on the Project Core Team (PCT).
  • To provide process validation support by applying GAMP 5 approaches to automated software in partnership with the Operations teams (especially automation)

Job requirements

  • Bachelor’s/Master’s Degree in Life Science, Chemistry, Engineering, Computer Sciences, Mathematics, Physics or equivalent technical degree;
  • At least 2 years of prior Software Quality experience in the IVD industry or the medical device industry;
  • At least 2 years of experience in a product development environment;
  • Knowledge of Quality System standards/regulations (IEC 62304, ISO 13485, 21 CFR 820);
  • Required fluent English. Knowledge of Dutch is an asset;
  • You're entitled to live and work in Belgium;
  • Some travel is required

Personal Competencies:

  • You work well in a team but equally can operate autonomously with personal accountability for objectives;
  • Ability to analyze and interpret technical procedures and governmental regulations;
  • Ability to create technical reports, business correspondence, technical procedures, as well as, administrative procedures;
  • Ability to present proposals, data, and issues to miDiagnostics personnel at all levels;
  • Aptitude for problem solving. Solutions must be thorough, practical, and consistent with organization objectives;
  • Ability to represent the team in frequent cross-functional interactions with regulators, subcontractors, and/or vendors;
  • Ability to determine and develop technical solutions to a wide range of difficult problems.