מדעים/ביוטק

QA/RA manager

859400

תאריך עדכון

07/12/2021

תיאור המשרה

ROLE AND RESPONSIBILITIES

Overlook all QA/RA activity of a fast-growing company, focused on Software, both in Israel and US:

· Implementation of QMS and SDLC

· Ensure that QMS requirements are effectively established and maintained

· Manage, maintain, and verify compliance with regulatory standards, to include:

o HIPPA, GDPR

o ISO 27001

o ISO 13485

o FDA compliance process

· Provide leadership, guidance, and corporate-level oversight to product quality teams, and other

employees with responsibilities related to regulated products

· Create and maintain regular lines of communication and training to promote quality awareness,

regulatory partnership, and harmonization of quality processes

· Conduct internal audits and lead external audits while providing guidance regarding best practices and

continuous improvement

· Manage key quality and regulatory affairs initiatives to drive continuous improvement

QUALIFICATIONS AND EDUCATION REQUIREMENTS

· A minimum of 5+ years of experience in the development, implementation, and maintenance of a QMS

(including SDLC) in a software company

· Broad knowledge of medical-related regulations focused on software - A Must

· Highest standards of accuracy and precision; highly organized, detail-oriented and mindful of deadlines

· Able to work under pressure and extensive working hours as needed, in a fast-paced and changing

environment

· Able to lead processes and activate subcontractors and co-workers, as well as work independently

· Fluent written and spoken English

PREFERRED SKILLS

· Experience in FDA approval processes

· High skills in MS Office tools

ADDITIONAL NOTES

EXCELLENT interpersonal skills and teamwork 

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