Software Quality Assurance Engineer

仕事内容

About miDIAGNOSTICS

miDiagnostics is using silicon chip technology that will bring miniaturized, lab-quality tests with built-in device connectivity and rapid results direct to the patient and clinician. Combining a nano-fluidic processor on a chip and a compact reader, miDiagnostics can measure virtually any biomarker from an easily accessed sample such as a single drop of blood. The Company is developing an extensive portfolio of tests for screening, diagnosis and monitoring of a wide range of health conditions, including infectious diseases. Spun out of the world-leading R&D and innovation hub in nanoelectronics and digital technologies, imec, and a research collaboration with Johns Hopkins University, the leading US research and medical centre, miDiagnostics’ goal is to enable fast, comprehensive and cost-effective health analysis, regardless of location. Based in Leuven, Belgium, miDiagnostics is a privately-held company created in 2015.

The Job

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).

Your profile and competencies

• 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 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;
• Our offices are located in Leuven (Belgium). Relocation to Belgium is needed. It is essential that you hold entitlement to work and live in Belgium;
• Some travel will be required.

The offer

• A job in a fast-growing and ambitious start-up in the medical diagnostics industry.
• miDiagnostics is an international-oriented company with close connections to two world-class research institutions (imec and Johns Hopkins University).
• Opportunity to grow in a new and exciting cutting-edge field in point-of-care diagnostics.
• Our offices are located in Leuven (Belgium). Relocation to Belgium is needed.

Interested? Please apply via our career website https://jobs.midiagnostics.com/