QA Regulatory Specialist - Medical Devices

3D Diagnostix - Cairo

112
Applicants for
1 open position
105
Seen
1
Shortlisted
103
Rejected
Experience Needed:
More than 2 years
Career Level:
Experienced (Non-Manager)
Job Type:
Full Time
Salary:
Confidential, 10% MBO (Management By Objectives)
Education Level:
Bachelor's Degree at least
Languages:
English
Vacancies:
1 open position
About the Job

Summary of Position:

  • We are looking for a detail-oriented Quality Assurance Specialist to be in charge of all quality assurance activities.
  • The Quality Assurance Specialist's responsibilities include developing and implementing quality assurance policies, conducting tests and inspections, identifying production, process, or product issues, and presenting solutions.
  • A QA Specialist is responsible for quality assurance audits and ensures product integrity and that standards are being met. A good QA specialist will know how to troubleshoot systems to ensure reliability, usability, and performance.
  • To be successful as a Quality Assurance Specialist you should be incredibly thorough and able to help our
  • The company maintains the highest quality standards.

Essential Duties and Responsibilities:

  • Prepare and implement quality assurance policies and procedures.
  • Perform routine inspections and quality audits.
  • Identify and resolve workflow and production issues.
  • Ensure that standards and safety regulations are observed.
  • Address and discuss issues and proposed solutions with superiors.
  • Document quality assurance activities and creating audit reports.
  • Make recommendations for improvement.
  • Create training materials and operating manuals
  • Handle Non-Conformity Reports.
  • Define root causes in CAPA and NC Reports.
Job Requirements

Qualifications:

  • Bachelor Degree (Pharmacy, Science, or Engineer).
  • Minimum 2 years’ experience in Medical Device Quality Assurance.
  • Working knowledge of tools, methods, and concepts of Quality Assurance.
  • Experience with ISO 13485:2016 Requirements.
  • Experience with MDD (Medical Device Directive 93/42/EEC as amended by 47/2007).
  • Solid Knowledge of Risk Management System (ISO 14971).

Competencies & skills:

  • Excellent communication skills, both verbal and written.
  • Excellent data collection and analytical skills.
  • Strong attention to details
About this Company

3D Diagnostix started the digital CT scan conversion business for dentistry in 2005, supporting the CT imaging department for a leading dental school with 3D reconstructions of oral maxillofacial cases. This need arose from a desire from dental clinicians to advance... (More)

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