QA/RA Manager

  • Gurugram
  • Medorah Meditek Pvt Ltd
Job Title : QA/RA Manager Experience Required : 10+ Years Location : Gurugram // Delhi -NCR Job Description: ·  Manage the QA/RA team ·  Author and refine procedures, instructions, templates, and our quality manual to maintain quality management standards. ·  Maintain and monitor our quality system within the company: changes, CAPA, Non-conformities, Complaints, PMS, continuous improvement, trend analysis, etc. · Train all employees to the QMS, and assess skills, knowledge and QMS application. ·  Perform internal audits to assess the company compliance with our QMS. ·  Contribute to maintaining quality system related documentation including supplier records, audits, purchase and manufacturing batch information. ·  Work with our Notified Body to maintain current certifications and achieve award of a CE mark and FDA approval on new products. ·  Build knowledge and maintain surveillance of the many relevant quality standards. ·  Provide technical support and resolve quality issues with suppliers, customers or auditors including introduction of new or re-designed components and processes. ·  Present technical data to internal / external audit and inspection groups as required. Attributes: ·  Minimum 10 years of Medical device QA/RA experience, 3 years of relevant experience in RA ·  In depth familiarity with the FDA, ISO, MDD, EU MDR and the medical device industry quality requirements associated with product development, design controls, and product risk management. · Quality Management experience in a manufacturing/production environment. · Conscientious and responsible · A keen eye for detail and a results driven approach · Strong communication and presentation skills. · Excellent organizational and leadership skills · Proficient in MS Office · In depth understanding of quality control procedures and relevant legal standards · Excellent math abilities and working knowledge of data analysis/statistical methods If you are a passionate individual to join our team, we want to hear from you! Please submit your resume at hr@medorah.com Join us in our mission to Improving lives….