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 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

Robust 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