Quality Assurance

QA Director

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Location: Israel

Commitment: : Full time

We are looking for a talented and highly driven QA Director to join our team.

Responsibilities:

  • Management of all Quality activities in the company.
  • Initiate, monitor, and verify the effective implementation of the Quality Management .
  • System and Regulatory requirements that impact processes, products, or services.
  • Maintain Dot Compliance internal QMS.
  • Maintain the quality documents and records.
  • Manage the validation team and product validation.
  • Responsibility for review and approval of relevant documentation such as SOPs,
  • Validation docs etc.
  • Responsibility for maintaining ISO 9001 quality certification.
  • Responsibility for supporting customer audits.
  • Responsibility for compliance with CFR part 11, Annex 11, and other guidelines.
  • Serve as company privacy officer as per privacy guidelines

Requirements:

  • B.Sc. or equivalent degree.
  • At least 5 years of experience as QA Manager in the Medical Device/Pharma/Biotech/Healthcare arena -Mandatory.
  • Tech Savvy and experienced in software validation methodologies.
  • High sense of ownership and ability to deliver independently.
  • Outstanding leadership, communication, interpersonal, and analytical skills with the ability to successfully lead multiple teams in highly dynamic matrix.
  • Analytical and technical skills and experience with supplier audits.
  • Excellent English (Verbal and Written), Outstanding communication skills.
  • Must use creativity, independent judgment and organizational and problem-solving skills.
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