QA/RA Manager

1 month ago

Pune, 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 hr@medorah.com


Join us in our mission to Improving lives….

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