Quality Assurance Specialist


Being a part of Quality Assurance/ Regulatory Affairs team, the QA Specialist plans, implements and manages quality control and quality assurance activities required for timely completion and shipment of the quality products, and is responsible for maintaining and ensuring that the company’s Quality Management System complies with requirements of ISO13485.


Principal Responsibilities

  • Maintain effectiveness of the Company’s Quality Management System in compliance with ISO 13485:2016 MDSAP, company’s Quality Policy and the established SOPs;
  • Manage receiving inspection, in-process inspection and final inspection to ensure safety and effectiveness of all products produced by the company;
  • Support root cause analysis process and other problem-solving activities to identify effective corrective actions and process improvements to ensure all customer complaints are addressed in a timely manner;
  • Organize and participate in quality system internal audit and supplier quality audits;
  • Apply statistic technique to monitor and control manufacturing process and provide trend analysis on the performance of O-Two products for continuous improvement;
  • Assist Regulatory Affairs function in the assembly Technical Files/ Device Master Records;
  • Establish supplier quality requirements and evaluate and monitor supplier’s performance to ensure O-Two required specifications are met;
  • Evaluate and maintain precision and accuracy of testing and measurement equipment;
  • Educate and train employees on SOPs, working instructions and procedures.

Educational Qualifications:

  • BSc or equivalent in Industrial Engineering, Process Engineering or a similar program preferred
  • At least 5 years Quality Assurance/Quality Engineering experience within medical device or biotech manufacturing environment
  • ASQ CQE preferred

Knowledge & Skills:

  • In-depth knowledge of ISO 13485 MDSAP quality management systems;
  • Working experience in medical device industry with assembly processes is desirable;
  • Experienced in identifying root cause(s) of non-conforming products and developing appropriate preventive actions;
  • Excellent attention to detail is essential;
  • Strong communication and interpersonal skills.

E-mail: resuscitation@otwo.com with your resume and find out how we can grow together!

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