Auditor - Medical Device Quality Systems

03/06/20

Location

Gaston Geenslaan 1 Leuven Belgium

Function type

quality and audit

Vacancy

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 Auditor - Medical Device Quality Systems, you will report to the VP Quality and Regulatory Affairs.

You will:

  • lead internal and supplier audit programs for the business. This includes the preparation of audit schedules / plans and the creation of a detailed suppler assessment program in combination with operational and R&D goals.

  • audit suppliers. This includes contractors, sub-contractors, suppliers of service as well as suppliers of parts/materials

  • manage the internal audit schedule, plan vendor management and report to management of key quality metrics

  • train internal auditors and build towards the creation of a cross-functional audit team

  • be a key leader within the quality and regulatory team. This includes working on quality strategy, failure investigation, product performance analysis, validations, etc

  • collaborate on the creation of corrective action plans, with the auditee, when audits highlight opportunities for improvement

  • need to make sure that all relevant data collection, analysis and review activities are carried out to a high standard and can be both audited and defended

  • need to make sure that all activities meet the requirements of ISO 13485 and 21 CFR 820

  • be a champion of Design controls and data quality

Your profile

  • You obtained a master's degree / Ph.D. in a scientific discipline and have at least 4 years of relevant experience

  • You have a prior Quality experience in the IVD or medical device industry

  • Knowledge of the Quality Systems standards / regulations (ISO 13485, 21 CFR 820)

  • You are familiar with a variety of the statistical concepts and practices

  • You are able to create technical reports, business correspondence, technical procedures, as well as administrative procedures

  • You have the ability to represent the team in frequent cross-functional interactions with regulators, subcontractors and/or vendors

  • Ethical attitude and high integrity

  • You are fluent in English. Knowledge of Dutch or French is an asset

  • You are able to travel internationally if required (approx. 10% of your time)

  • Our offices are located in Leuven (Belgium). Relocation to Belgium is needed

Interested? Apply via our career website: https://jobs.midiagnostics.com/o/auditor

(NB: 'Submit application' via the Flanders Bio site isn't enough)

Job application