Quality Assurance Manager

4 weeks ago

Rawalpindi Cantonment, Pakistan Revive Medical Technologies Inc. Full time

1 day ago Be among the first 25 applicants

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Direct message the job poster from Revive Medical Technologies Inc.

Works at Revive Medical Technologies Inc.

Revive Medical Technologies Inc. is searching for a bright and enthusiastic QA Manager to join our growing team.

Education: Bachelor's or Master's degree in Biomedical Engineering, Quality Management, or related field.

Experience:


• 5–10 years of experience in Quality Assurance in the medical device industry.


• Proven experience with ISO 13485, 21 CFR Part 820, and EU MDR.


• Experience in audits and regulatory inspections.

Responsibilities and Authorities:


• Develop, administer and maintain Quality Management System in compliance with ISO 13485, FDA 21 CFR Part 820, EU MDR, and other applicable standards.


• Plan and lead internal and external audits (e.g., notified body, FDA, customer).


• Develop and manage document control procedures, CAPA, non-conformances, and change control processes.


• Conduct periodic management reviews meetings and quality system gap assessments.


• Oversee quality-related activities during design and development, risk management (ISO 14971), design validation/verification and production.


• Ensure quality compliance in manufacturing and supplier processes.


• Qualify, audit, and monitor suppliers/subcontractors for compliance with quality requirements.


• Lead incoming inspection and supplier non-conformance handling.


• Root cause analysis and implementation of corrective action for process related concerns.


• Approve and maintain Device Master Records (DMR) and Device History Records (DHR).


• Assist in regulatory submissions (national and international both) and maintaining technical files.


• Ensure alignment of quality documentation with global regulatory requirements.


• Organize quality training and awareness programs across departments.


• Drive initiatives for process improvement, waste reduction, and product quality enhancement.


• Monitor quality KPIs and prepare regular quality reports for management.

How to Apply:

submit your resume and cover letter to [hr@rmt-pk.com] with the subject line "QA manager - [Your Name]"

Seniority level
  • Seniority levelMid-Senior level
Employment type
  • Employment typeFull-time
Job function
  • Job functionQuality Assurance
  • IndustriesMedical Equipment Manufacturing

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