Deskripsi Pekerjaan
Are you a detail-oriented professional with a passion for quality standards in the medical technology sector? Forte Employment Services is seeking a dedicated Project Coordinator to join our engineering-focused team in Tuas. This role is pivotal in ensuring that our operational processes strictly adhere to the ISO 13485 international standard for medical device Quality Management Systems (QMS).
In this role, you will bridge the gap between project execution and regulatory compliance. You will be responsible for maintaining documentation, assisting with audits, and ensuring that all project lifecycles align with the rigorous safety and quality requirements of the medical device industry. This is an excellent opportunity for an early-to-mid career professional looking to specialize in high-stakes quality assurance and project oversight within a fast-paced manufacturing environment.
If you are analytical, process-driven, and looking to build a career in a high-growth sector, we invite you to apply.
Tanggung Jawab
- Support the implementation and maintenance of ISO 13485 QMS documentation and procedures.
- Coordinate with cross-functional engineering teams to ensure project milestones meet quality specifications.
- Assist in the preparation and execution of internal and external quality audits.
- Manage document control processes, ensuring all records are accurate, updated, and compliant with regulatory standards.
- Perform regular risk assessments and contribute to corrective and preventive action (CAPA) reporting.
- Monitor and track project timelines, identifying potential compliance bottlenecks before they impact production.
- Communicate regularly with stakeholders to provide updates on quality metrics and compliance status.
Kualifikasi
- Diploma or Degree in Engineering, Quality Assurance, Biomedical Science, or a related discipline.
- Hands-on experience or academic exposure to ISO 13485 or similar QMS standards.
- Strong understanding of document control and regulatory compliance in the medical device industry.
- Proficiency in Microsoft Office Suite and quality management software tools.
- Strong analytical skills with a meticulous eye for detail and data accuracy.
- Ability to work effectively in a manufacturing or plant environment located in Tuas.
- Excellent communication and coordination skills to manage stakeholder expectations.