A leading medical technology company is looking for a QA Engineer.
Responsibilities:
Manage the MRB process and handle nonconforming materials, including investigations, risk assessments and corrective actions.
Coordinate with Manufacturing, Engineering and Supply Chain to resolve quality issues.
Oversee equipment calibration, maintenance and qualification, ensuring compliance with quality procedures.
Support root cause analysis, CAPA and continuous improvement activities.
Maintain quality documentation and ensure compliance with ISO 13485, FDA regulations and QMS requirements.
Support customer complaints, system release and incoming inspections as needed.
Requirements: Bachelor's degree in Engineering or a related scientific field.
2-5 years of experience in QA or Supplier Quality within the medical device or regulated industry.
Knowledge of ISO 13485, FDA 21 CFR Part 820, ISO 14971 and GMP.
Strong documentation, organizational and communication skills.
Detail-oriented, proactive, and able to work cross-functionally.
ISO 13485 Auditor certification - advantage.
This position is open to all candidates.