Responsibilities
• 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, Nonconformities,
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 recent or re-designed components and processes.




• Present technical data to internal / external audit and inspection groups as required.

Requirements
• 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

📌 QA/RA Manager-PL (Delhi)
🏢 IAssess Consultants
📍 Delhi