Global Senior Computer Systems Validation Engineer – REMOTE

Job Overview

Job OverviewThe Global Computer Systems Validation Engineer will provide expert computer system validation support for the Global Enterprise Systems deployment in TE Medical.

What your background should look like:Experience/Qualifications:Bachelor or master’s degree in science/Engineer/Software discipline.5 years of related experience, including 3+ years’ experience supporting software quality/compliance or software assurance.Working knowledge of regional and international quality system requirements including 21CFR 820, ISO 13485, CFR Part 11 and cGxP. Experience with IEC 62304, IEC 82304, GDPR and ISO 14971 is an advantage.Must have a good understanding of quality system requirements and how each quality system element connects.Experience in working with “Agile” software development methodologies and can engage at a technical level with software development teams and testers is desirable.Comfortable speaking and presenting to leadership.Strong written and verbal communication skills.Fluent in EnglishCreative and innovative thinking skillsExperience managing projects and project deliverables to completion.Experience in S/4 HANA would be an advantageComfortable working independently and as part of a team.

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