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….