Quality Assurance Engineer

Responsibilities:

Maintain and develop the company’s QMS.

Ensure new product designs meet regulatory standards.

Monitor compliance and report issues.

Work on effective corrective actions with various teams.

Supervise company documentation.

Implementation of training program, and monitoring of employee training records.

Managing the supplier evaluation program, and supplier performance.

Conduct internal audits.

Monitoring of change control process.

Review and approval of maintenance and calibration records.

Review and approval of validation records.

Handle and investigate customer complaints

Requirements:

Bachelor’s degree in Engineering, Life Sciences, or a related field. A Master’s degree or relevant certification (e.g., ASQ, CQE) is a plus.

Minimum of 5 years of experience in quality assurance within the medical device industry.

Experience with regulatory requirements and standards (e.g., ISO 13485, FDA 21 CFR Part 820, EU MDR).

Proficient English level and good verbal English.