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 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

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

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