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, 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.

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

• 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:- QA, QMS, Production and FDA, ISO, MDD, EU MDR

📌 QA/RA Manager (Delhi)
🏢 Hunarstreet Technologies
📍 Delhi