Technical Writer - Engineering
6 months contarct with potential to extend
We are looking for innovative candidates to be a key contributor in supporting the development of software product that impact on patient lives. The candidate will support R&D with primary responsibility for the hands-on management of documentation supporting software diagnostics product development and on-market product improvements. This candidate will work closely with cross-functional teams to write, edit, review and finalize technical documents required for software products which includes but not limited to documents involving design control deliverables, verification and validation protocols and reports, and other documents associated with the phase-gate development of new products and the transfer of products from R&D to production.
This role will be dedicated to managing and updating Safety Data Sheets for in vitro diagnostic products. In addition, the role will assist the Regulatory Affairs team in preparing documentation including supporting administrative activities.
The ideal candidate will be a true team player, with strong Project Management skills . This is an opportunity for a highly motivated candidate to work alongside chemists, molecular biologists, and quality engineers in a fast-paced environment.
•Liase with groups in several geographic locations, to update Safety Data Sheets.
•Perform document reviews and makes determinations as to whether document meets procedural and regulatory expectations. Communicates and coordinates with other departments as required to resolve issues detected during review.
•Submit and complete document change requests.
•Maintain tracking sheets and report out project status updates. Follow up with team members to ensure timely implementation of updates.
•Support Regulatory Activities by preparing and assembling documentation for international registrations as required.
•Bachelor’s Degree in a science, engineering or related field.
•Experience in IVD field
•Must be able to work independently taking general concepts and direction to produce desirable compliant outcomes.
•Ability to prioritize multiple tasks and to function effectively in a global, multi-site organization.
•Detail-oriented and accurate while maintaining a vision of the end result.
•Excellent verbal and written communication skills
•Skills in Microsoft Office
•Ability to work in a fast paced environment
•Must be highly collaborative, have the ability to work within a diverse team, and contribute to a supportive, positive work environment both within the team and in the greater site-wide community
Kelly puts you in charge of your career, with access to cutting edge projects and technologies in industry leading organizations. Top companies throughout the world have trusted Kelly as a premier source of engineering talent and services since 1965. And engineering job seekers know Kelly as a firm with an unmatched reputation for quality, integrity and professionalism. Whether you seek the variety and flexibility of working on short term project engagements, or prefer contract-to-hire or direct hire placement with our clients, apply with Kelly to explore opportunities that suit your specific professional interests.
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Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is committed to employing a diverse workforce. Equal Employment Opportunity is The Law.