Quality Assurance Manager

Description:

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.