Manager, Commercial Quality

Johnson & Johnson MedTech

Mumbai, India
Quality management system
Regulatory standards compliance
Supplier management monitoring
Establishes and maintains quality assurance programs, procedures, and controls for various elements of the JJMTI Quality Management system

Job Summary

  • Establishes and maintains quality assurance programs, procedures, and controls for various elements of the JJMTI Quality Management system.
  • Ensures that performance and quality of products / services conform to established company and regulatory standards.
  • Facilitates 3rd Party audits, i.e. Notified Body, FDA and other regulatory agency compliance inspections, internal and supplier’s audits as well as Corporate audits and coordinate responses.

Matching Summary

Establishes and maintains quality assurance programs, procedures, and controls for various elements of the JJMTI Quality Management system.

Skills & Requirements

Must-have

  • Quality Management System
  • Regulatory Standards Compliance
  • Supplier Management Monitoring
  • Corrective and Preventive Actions
  • Complaint and Adverse Event Reporting

Nice-to-have

  • Business Savvy
  • Coaching
  • Continuous Improvement
  • Fact-Based Decision Making
  • Problem Solving

Key Requirements

  • 12-14 Years of experience
  • Science Postgraduate or Bio Medical Engineer
  • ISO lead auditor certification (QMS) preferred
  • ASQ Quality Auditor certification preferred
  • FDA Approval preferred

Work Rights

Not specified

Tailored Resume

Cover Letter