miDiagnostics is developing a new generation of disposable tests that require only drops of blood and allow 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.
- Wwork with the development teams to develop and execute plans (quality plan, risk management plan) and requirements (safety, functionality, regulatory, usability) to ensure provisions for quality are addressed and resolved prior to release
- 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
- Work closely with the development teams to develop the appropriate verification test plans and validations studies, and qualifications (subcontractors, system and subsystem)
- 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
- Participate in the change control process to review and approve engineering change requests
- Povide process validation support by applying manufacturing quality tools including, but not limited to: FMEA, IQ, OQ, PQ, control plans, process verification/validation plans, Cpk, Cp, SPC, DOE, process and DMAIC
Profile and competences
- Bachelor’s Degree in engineering, Electrical, Mechanical, Industrial, Biotechnology, Engineering Technology or equivalent technical Degree; or equivalent combination of education and experience
- Prior Quality Engineer experience in the IVD industry or the medical device industry
- Knowledge of Quality System standards/regulations (ISO 13485, 21 CFR 820)
- Ability to read, analyze, and interpret technical procedures and governmental regulations.
- Ability to write technical reports, business correspondence, technical procedures, as well as, administrative procedures
- Ability to present proposals, data, and issues to miDIAGNOSTICS personnel at all levels
- Ability to independently determine and develop an approach to a wide range of issues and problems. Solutions must be thorough, practical, and consistent with organization objectives
- Ability to represent the department in frequent cross-functional interactions and possible customer, subcontractor, or vendor contacts
- Ability to provide solutions to difficult technical issues associated with specific projects
- 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)
- You will be part of an international and multidisciplinary team
- You can further grow in a new and exciting cutting-edge field in point-of-care diagnostics
Please apply by e-mail to email@example.com with reference to this opportunity.