QA/RA Manager

3 weeks ago


Gurgaon, India Medorah Meditek Pvt Ltd Full time
Job Title : QA/RA Manager 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 of 5 years of Medical device QA/RA experience. ·

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 Join us in our mission to Improving lives….
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