QA/RA Manager

Job Title : QA/RA Manager

Experience Required : 10+ Years

Location : Gurugram // Delhi -NCR

Job Description:

· 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.

Attributes:

· Minimum 10 years of Medical device QA/RA experience, 3 years of relevant experience in RA

· 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

· 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

If you are a passionate individual to join our team, we want to hear from you! Please submit your resume at

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