Quality Engineer


About the job

Duties and Responsibilities

• Maintain and sustain the effectiveness of ISO-certified, FDA complied QSR and EU MDR. (i.e.13485, 21 CFR Part 820 and MDR 2017/745).

• Deploy and maintain Quality Systems SOPs and WIs.

• Monitor and maintain quality objectives meeting quality policy.

• Informed of the latest ISO and QSR requirements and updating of Quality Systems documentation.

• Conduct training on changes relating to Quality Systems.

• Schedule and perform internal audit activities including management of internal audit team, pre-audit planning, audit execution, evaluation and post-audit follow-up and recommendations.

• Support 3rd party audit activities including pre-audit planning, audit readiness, and post-audit follow up with external auditor.

• Function as Document Controller for the initiation, revision and release of ISO/QSR documents.

• Function as Complaint Coordinator to ensure complaint/feedback been addressed and documented for closure.

• Assist in the development and implementation of corrective and preventive action plans to improve overall ISO/QSR compliance and quality results.

• Assist in product design review for Medical Device and Software as a Medical Device (SaMD).

• Develop orientation program and conduct training to new hire on QMS/QSR Awareness.

• Monitor and maintain CAPA process.

• Responsible to in-coming, in-process and out-going processes ensuring product meets specification.

• Perform data analysis and recommend improvement on product quality/processes.

• Prepare Quality Management System performance indices during Management Review.

• Responsible to Supplier Management process.

• Quality responsible for Contract Manufacturing activities

• Other jobs assigned by Supervisor.


· Review and Approval QMS documents.

· Accept and reject of CAPA investigation and closure.

· Accept and reject of internal audit findings.

· Accept and reject of product non-conformity.

· Report and escalation of Quality performance.

· Determine supplier quality and evaluation performance.

Experience / Training:

• At least 2 years (or 5 years for Diploma) experience in a manufacturing or software development of Medical Device environment.

• Good understanding of the Quality System Requirements like ISO 13485 and Part 820.

• Hands-on experience in ISO13485 and QSR implementation is an advantage.

• Experience in conducting/leading Quality System audits.


• Bachelor’s degree in Engineering


• Ability to independently manage and drive a cross-functional team to accomplish the various QS-related tasks

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