QA/RA Manager-PL (New Delhi)

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 setting. Conscientious and responsible A keen eye for detail and a results driven approach Strong 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 Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying. .