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חברת השמה / כח אדם

4 ימים

Software Quality & Regulatory Specialist

חברה חסויה

Location: More than one

Job Type: More than one

Full Time

Multilingual

May Be Suitable For Religious Sector

English Speakers

Russian Speakers

Arabic Speakers

This position is responsible for supporting the EME software development team for software quality activities, and the sales and marketing team to ensure regulatory compliance with markets served by the EME division.
Shall include, but not limited, to the following:
Generating documentation to support medical device software development including requirement specifications, risk analysis, test procedures, test plans, and traceability matrices that will maintained within the design history file.
Executing software test plans to ensure that the device meets product and system requirements.
Initiate or assist in investigation and resolution of both product quality and process issues.
Regularly communicate quality and regulatory data to Senior Director, Quality & Regulatory.
Other tasks as may be assigned by the Senior Director, Quality & Regulatory.

Requirements:
o Bachelor degree, or equivalent (Biology, Chemistry, Life Sciences, Biotechnology, Biomedical Engineering).
o Training and working knowledge of quality systems standards such as FDA QSR and ISO 13485 preferred.
o Proficient in Microsoft Word and Excel.
o Fluent in English.
o Excellent written and verbal communication skills.
o Adherence to internal quality system procedures.
Software Quality Role
o Technical writing experience preferred as generation and maintenance of software development documentation is required.
o Understanding of product development process in a regulated industry such as medical devices.
o Ability to perform verification and validation (system-level) testing of software releases and communicating results to Product Development group for formal product release.
Interface directly with quality & regulatory, software development, and product management groups.

הגשת מועמדות

5907785