QA Engineer | Enea Romania | 0LOVES1
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We're not saying it's gonna be easy.
But we promise it's not gonna be boring.

We pride in providing new challenges all the time for our creative, rebellious engineers. This is the kind of place where we want to change the world with the right lines of code. Insane passion, curiosity and thirst for breaking barriers and rules feel like home here at Enea.

Would you feel like home?

QA Engineer

Location: Bucharest, Remote

Number of positions available: 1

Job Type: Full Time

Division: Services Division, ENEA Romania

WE'RE NOT SAYING IT'S GONNA BE EASY. BUT WE PROMISE IT'S NOT GONNA BE BORING. We pride in providing new challenges all the time for our creative, rebellious engineers. This is the kind of place where we want to change the world with the right lines of code. Insane passion, curiosity and thirst for breaking barriers and rules feel like home here at ENEA. Would you feel like home?
 

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Job description

Position objectives

The position of Quality Engineer is within our verification team that manages testing and verification for medical devices. This role will lead the software verification and validation activities for our next generation of diagnostics platforms product software and non-product software in one or more projects. In support of these goals, ENEA believes that specific systems engineering technical expertise with a rich history in complex system verification techniques, test environments, system integration and validation is crucial to the successful deployment of Abbott’s test automation system and support of the Digital and ID Now products.

Working with cross-functional teams you will be responsible for ensuring accuracy, consistency, and robust documentation for the design, develop, and testing of software applications embedded in diagnostic and interventional cardiology devices.

Contacts & Supervisory responsibilities

  1. Work closely with the entire working team, which is providing you support for the daily technical jobs, and with the Project Lead and Program Manager which is empowering your skills and expertise by providing the needed knowledge, information and resources
  2. Ensure close communication and working relationship with R&D, regulatory, quality, PMO and other necessary functional teams
  3. Provide supervision and mentorship to staff for their development and performance reviews
  4. Provide updates to Senior Management team as required
  5. Essential functions

    1. Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
    2. Work with design engineering in the completion of product verification and validation
    3. Contribute significantly to completion of various project activities, from definition, use cases, identifying software functional requirements, IFU reviews, and final submission documentation according to medical device development processes
    4. Design and conduct experiments for process optimization and/or improvement
    5. Appropriately document experiment plans and results, including protocol writing and reports
    6. Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices; build productive internal/external working relationships
    7. Participate in scrum meetings and follow internal software development, cyber security, and validation procedures that comply with medical and security regulations
    8. Participates in product/process improvemen
    9. Performs other related duties and responsibilities, on occasion, as assigned

    Required key skills

    1. Experience in testing solutions from technical designs, specifications, requirements
    2. Experience in reporting and documenting software defects
    3. Experience in maintenance and execution of automation test protocols
    4. Experience in managing and maintaining a large set of technical documentation
    5. Demonstrable working experience in technical writing of software documentation
    6. Excellent written skills in English

    Qualifications

    1. Bachelor of Science in Computer Engineering, Computer Science or equivalent. Three to six years of related work experience is required
    2. Engineering experience and demonstrated use of Quality tools/methodologies
    3. Product validation and verification experience
    4. Strong written communication skills or excellent documentation skills (highly regulated development environment)
    5. Strong verbal communication and interpersonal skills

    Great to have

    1. Experience in delivering products for the Medical Device industry or IVD experience
    2. Experience testing physical devices
    3. Familiar with testing of healthcare communication protocols (e.g. ASTM, HL7, POCT1A
    4. Experience owning software and non-software product documentation through full product life cycle

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