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