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 environment.
- 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

📌 QA/RA Manager (Gurugram)
🏢 Medorah Meditek
📍 Gurugram