Senior QA Specialist

20 hours ago

Central Singapore Emprego SG Full time

**Location**
- Singapore, Central Singapore**Job Type**
- Permanent**Salary**
- $5,000 - $6,000 Per Month**Date Posted**
- 3 hours agoAdditional Details

**Job ID**
- 98844**Job Views**
- 1Roles & Responsibilities

Our client is a biotechnology company specializing in developing proprietary non-invasive medical devices.

The company is certified to EN ISO 13485:2016 for design and development of medical devices and they currently have a newly created opportunity for a qualified Specialist to join their growing team.

**Senior QA Specialist (Medical Devices)**

**Key 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.
- Manage the document control, engineering change control, and records control process including external origin documents.
- Evaluate, monitor suppliers. Maintain the Approved Supplier List (ASL).
- Manage the internal audit program to ensure timely execution in accordance with published schedule.
- Manage the calibration program to ensure all monitoring and measuring equipment are inducted, calibrated, reviewed, and monitored in a timely manner.
- Participate in risk management and development activities throughout the lifecycle(s) of medical devices.
- Participate in risk assessment (FMEAs and SHA) and risk control activities of device design, use, and manufacturing.
- Participate in the validation of analytical test methods and process validations used in the quality management system.
- Participate in the preparation of premarket regulatory submissions for commercial distribution.

**Pre-requisites**:

- Bachelor of Science degree in a scientific (chemistry, biochemistry, microbiology) or engineering (biomedical) discipline.
- Minimum of 5 years of quality management system (ISO13485) experience in the medical device industry.
- Strong verbal and written communication skills.
- Strong analytical, time management and organizational skills.
- Have a positive, proactive, can-do attitude, wiling to learn.

**We regret only shortlisted applicants will be notified**

Tags

senior

qa

specialist

medical

devices

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