ASSISTANT MANAGER QUALITY ASSURANCE

Manufacturing Industry

Profile – ASSISTANT MANAGER QUALITY ASSURANCE

Qualification – Diploma/B.E. /B.Sc. degree, masters may be preferred

Experience – Min. 10+yrs. (in medical devices manufacturing)

Salary – Upto 10.20 LAC

Location – New Delhi

Job Description

Excellent computer skills
 Goal Oriented
 Strong communication skills, including the ability to explain and teach methodologies
 Understanding of manufacturing methods and quality standards
 A confident and determined approach
 Excellent organizational & time management skills
 Excellent team handling skills

To act as a Management Representative and fulfil the responsibilities as defined in ISO
13485:2016 standard as given under-.
 Ensuring that the processes needed for the Quality Management System are
documented with the support of Quality System Manual, SOPs, and Records.
 Reporting to the top management on the effectiveness of the Quality
Management System and any need for improvement.
 Ensuring the promotion of awareness of applicable regulatory requirements and
quality management system requirements throughout the organization.
 Planning and conducting the Management Review Meetings (MRM).
 Planning and conducting the Internal Quality Audits.
 Issuing of documents after approval by Top management
 Quality Policy implementation
 Quality Objectives – Establishment and follow ups

To act as a Manager / Head / In-charge, Quality Assurance and fulfil the
responsibilities as given under-
 Develop, administer and maintain quality assurance procedures and activities
required to ensure that the company's processes and products are in compliance
to the medical device quality standards and requirements
 Coordinate and steer monthly product quality meetings
 Customer Support [Documental and Technical]
 Receipt of customer complaints and resolving the same.
 Implementing customer specified requirement in the plant for production
purpose.
 Overall responsible for process control as per defined procedure and need of
customers
 Ensuring Training need identification and conducting
 Failure investigation, product complaints and lead corrective and preventive
actions
 Assessment of the suppliers.
 Investigation & Disposition of NC product at all stages.
 Validation of Processes, Equipment’s and Machines – Plan and Conduct
 Stability Studies
 Batch Production Records Controlling and signing
 Customer Feedbacks – Follow up with sales and Data Analysis
 Annual Product Review