Quality Assurance (QA) / (RA) Specialist

Roles & Responsibilities

• Serves as the Management Representative to monitor and report on the adequacy, effectiveness

and continuing suitability of the company’s Quality Management System (QMS) in accordance

with ISO 13485 : 2016, established policies / procedures, and applicable regulatory requirements.

regulations and standards.

external origin documents.

schedule.

calibrated, reviewed, and monitored in a timely manner.

the lifecycle(s) of medical devices at BioCheetah. Participate in risk assessment (FMEAs and SHA)

and risk control activities of device design, use, and manufacturing.

software used in the quality management system, production, and monitoring / testing.

corrective / preventive actions, and disposition of affected products.

Qualifications :

(biomedical) discipline.

industry. IVD experience is highly preferred.

are strongly preferred.

We regret that only shortlisted candidates will be notified.

Tell employers what skills you have

Biochemistry

Risk Assessment

Quality Management

ISO

Investigation

Microbiology

Medical Devices

Change Control

Design Control

Regulatory Requirements

Regulatory Submissions

Manufacturing

Software Development

Calibration