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 recent 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.

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 setting.
Conscientious and responsible
A keen eye for detail and a results driven approach
Solid 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

Skills: mdd,iso,ra,eu mdr,qa,fda,quality analyst

📌 Qa/ra Manager Pl Delhi
🏢 IAssess Consultants
📍 Delhi