QA Engineer

Yesterday

Apply Now

Receive Emails with Similar Jobs

Sol-Millennium Medical Group

WebsiteLinkedInAll Job Openings

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

201 - 500

Description

• Provides hands-on support of the Company's Quality Management System • Assures the full implementation of the complaint handling/vigilance system • Compliance to international regulatory requirements • Provides documentation in support of regulatory submissions and customer requests • Supports the complaint evaluation and investigation, including failure analysis • Maintains all relevant complaint handling and vigilance documents in a compliant manner • Establish, follow, and maintain Quality Management System procedures, work instructions, and other processes • Interact and coordinate activities with other departments, external vendors, and customers • Support internal, external, and customer audits of the SQA program • Identify areas of improvement and implement plans to correct and prevent problems

Requirements

• A diploma, certificate or other evidence of formal qualification, awarded on completion of a university degree or of a course of study recognized as equivalent by the Member State concerned, 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 or four years 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