QA Engineer

3 days ago

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Sol-Millennium Medical Group

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Manually retractable safety syringes • Safety Needles and syringe combinations • Safety Needles • Safety Blood Tube Holders • Medical Devices

201 - 500 employees

⚕️ Healthcare Insurance

💊 Pharmaceuticals

🧬 Biotechnology

Description

• Provides hands-on support of the Company's Quality Management System • Assures full implementation of the complaint handling/vigilance system • Ensures regulatory compliance • Maintains quality and regulatory documentation • Supports implementation and execution of regulatory compliance requirements • Supports trending and risk analysis • Maintains all relevant complaint handling and vigilance documents • Communicates effectively and in a timely manner to customers • Supports internal, external, and customer audits of the SQA program • Identifies areas of improvement and implement plans to correct and prevent problems

Requirements

• A diploma, certificate or other evidence of formal qualification in law, medicine, pharmacy, engineering or another relevant scientific discipline • At least one year of professional experience in regulatory affairs or in quality management systems relating to medical devices • Knowledge of the medical devices EU regulations • Knowledge of the ISO 13485 or ISO 9001 standards • ASQ certification (Certified Quality Quality Engineer, Certified Quality Auditor, Certified Quality Engineer) • Experience in Quality Assurance for medical devices • Good working knowledge of the Microsoft Office • Writing and approving standard operating procedures and work instructions • Experience in auditing • Experience in the manufacturing and design of medical devices • Experience in the quality control and quality assurance of medical devices/PPE products/Biocides/Cosmetics or Veterinary products