Onera has multiple career opportunities

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  • Creator
    Topic
  • #90873
    Terry Boyd
    Keymaster

    Onera, Eindhoven and Palo Alto

    Onera came out of HighTechXL’s 2017 cohort and has been growing ever since. In that time, the team – led by co-founders Soukaina Adnane and Ruben de Francisco – has been perfecting next-gen medical grade sleep diagnostics. This is a spin-off company of Leuven, Belgium-based R&D hub IMEC and Holst Centre, TNO’s R&D operations on High Tech Campus Eindhoven.

    Onera raised 8.5 million euros in a Series A led by Jazz Pharmaceuticals, imec.xpand and includes imec and BOM. It just got it CE Mark in Europe for its Polysomnography (PSG) device.

    Job openings include:

    QUALITY MANAGER

    Job Description

    You will be involved in medical device compliance activities throughout the whole lifetime of our products.

    Key Responsibilities
    You will be part of a multidisciplinary, energetic, young, and international start-up team. You will help to ensure that our products are in compliance with applicable medical device regulations and with our Quality Management System.

    • Establish and maintain Onera’s Quality Management System (QMS)

    • Establish and maintain the Quality policies

    • Liaise with other managers and the Onera team, provide training, tools and techniques to enable others to achieve the quality objectives

    • Follow-up and handling of Corrective and Preventive Actions (CAPAs) and QMS improvement     opportunities

    • Support internal and external audits

    • Work with procurement staff to establish quality requirements/control for external suppliers

    • Work with manufacturing staff to ensure that the manufacturing/production processes meet the quality standards

    • Ensure good documentation practice

    Profile

    • BSc or MSc in life sciences, engineering or similar

    • At least 4 years of relevant work experience

    • At least 1 years in the medical device industry in quality assurance preferred

    • Knowledge of ISO13485, 21 CFR 820

    • Structured thinking, autonomous and ability to prioritize

    • Skilled in numerical and statistical analysis

    • Attention to detail

    • Enjoy a dynamic, diverse, and flexible work environment

    • Legally authorized to work in the Netherlands (already possessing a visa/EU residence permit)

    • Good communication skills in English (written and spoken)

    • Positive attitude, can-do mentality, and flexibility – much needed in a startup!

    Contact
    Apply by email to:

    [email protected]

    Onera has other openings including

    project manager, medical devices

    systems architect, medical devices

    embedded software engineer, medical devices

    You can see them all here.

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