Quality Assurance and Regulatory
Affairs(QA & RA) Manager(
Mechanical Engineer)

Quality Assurance and Regulatory Affairs (QA & RA Manager):

A well established company manufacturing and exporting Surgical Devices invites applications from eligible candidates for appointment to the post of Quality Assurance and Regulatory Affairs (QA & RA) Manager.

Job Responsibilities:

• The QA & RA manager will be responsible for development and effective implementation of the company’s quality management system to fulfill requirements of ISO 9001:2008
• ISO 13485 quality management systems and FDA’s 21CFR
• Section 820 quality system regulation for Medical Devices.

Qualification:

• The candidate should preferably have masters in Total Quality Management and B.Sc. in Mechanical Engineering

Experience:

• The applicant must have a minimum work experience of 5 years in system development, implementation, and audit of ISO 9001:2008/ISO 13485 quality management system in a manufacturing industry.
• He should be a lead auditor for ISO9001:2008/ISO 13485 quality management system.

Competencies:

• The applicant should also have good IT skills, be highly motivated & result-oriented, and should have strong leadership qualities.