Development Quality Engineer
Development Quality Engineer
Gaston Geenslaan 1 Leuven Belgium
miDiagnostics is developing a new generation of disposable diagnostic tests that require a tiny drop of blood for detection of cells, proteins, nucleic acids, and/or small molecules. Its core technology is a novel silicon-based nanofluidic processor that automatically processes the blood sample without the need of pumps or valves. There is no need for complex and costly instrumentation enabling medical decisions to be taken at the point of need or remote areas with a high level of comfort to both patients and caregivers.
The Quality Engineer drives the quality activities within the development team. She/He will need to make sure that all the relevant design control activities are carried out to a high standard, in compliance with ISO 13485 and 21 CFR 820, and make sure that all the development team actively engage in the Design Control process.
To work with the development teams to develop and execute plans (design, development & quality plan (DDQP), risk management plan) and requirements (safety, functionality, regulatory, 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 design control deliverables including, but not limited to product specifications, design verification, design validation, design reviews and design transfer.
To work closely with the development teams to develop the appropriate verification test plans and validations studies, and qualifications (subcontractors, system and subsystem).
To review design inputs (specifications) and design outputs (reports, prints, etc.) to assure that appropriate design requirements are specified and to evaluate/confirm quality requirements prior to successful design transfer.
To partner with QA and RA functions including the document services team, in order to efficiently and effectively deliver necessary quality elements in accordance with the project plan.
Where necessary represent the QA/RA group on the Project Core Team (PCT).
To provide process validation support by applying manufacturing quality tools including, but not limited to: FMEA, IQ, OQ, PQ, control plans, process verification/validation plans, statistical techniques.
Profile and competencies
Bachelor’s Degree in Life Science, Chemistry, Engineering, Biotechnology, or equivalent technical Degree
Prior Quality experience in the IVD industry or the medical device industry.
Knowledge of Quality System standards/regulations (ISO 13485, 21 CFR 820).
Required fluent English.
Some travel is required.
Works 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.
Full-time job at a fast-growing and ambitious start-up in the biotech industry
Market competitive salary and benefits package
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
Interested? Please apply by e-mail to email@example.com with reference to this opportunity.