Deskripsi Pekerjaan
Are you a detail-oriented Quality professional looking to make an impact in the healthcare sector? The Supreme HR Advisory is seeking a dedicated Quality Compliance Officer to join our client's growing team in Woodlands. In this role, you will be the backbone of operational excellence, ensuring that our healthcare testing processes strictly adhere to international quality standards.
You will play a pivotal role in maintaining our laboratory's accreditation status, managing internal and external audits, and driving continuous improvement initiatives. If you are passionate about compliance, quality assurance, and laboratory standards, we invite you to apply and help us uphold the highest levels of accuracy and safety in clinical testing.
Tanggung Jawab
- Develop, implement, and maintain Quality Management Systems (QMS) in alignment with ISO 15189 and ISO/IEC 17025 standards.
- Coordinate and lead internal audits to ensure full compliance with regulatory requirements and laboratory protocols.
- Serve as the primary point of contact for external auditors and regulatory bodies during inspections.
- Document and investigate non-conformances, implementing effective corrective and preventive actions (CAPA).
- Conduct regular training sessions for laboratory staff regarding quality standards, safety protocols, and SOP updates.
- Monitor and analyze quality performance metrics to identify trends and areas for process optimization.
- Ensure all laboratory documentation is accurate, complete, and readily accessible for review.
Kualifikasi
- Bachelor’s Degree in Biomedical Science, Chemistry, Life Sciences, or a related field.
- Proven working experience in a quality assurance role within a laboratory or healthcare setting.
- Strong technical knowledge of ISO 15189 and ISO/IEC 17025 standards.
- Experience in conducting internal or external quality audits.
- Excellent analytical skills with a sharp eye for identifying procedural gaps.
- Proficiency in documentation control and regulatory reporting.
- Strong interpersonal skills with the ability to communicate compliance requirements effectively to cross-functional teams.