Job Description

QMS Operation and Maintenance (Focusing on ISO 13485) Development and revision of quality manuals, procedures (process-specific SOPs), and record formats, document change management, and consistency checks. All changes are managed as a package, including risk assessments and training implementation. Registration, tracking, and deadline compliance monitoring of key procedures, including nonconformance, change management, CPA, customer complaints, and audit corrective actions. Manufacturing and Process Quality Assurance (Supplier to Shipping) Establishment of standards for incoming inspections, process inspections, and shipping inspections, management of sampling and inspection records, and rapid escalation of process abnormalities. Complaints, Nonconformances, and CPA Reception, investigation, and root cause analysis (RCA) of customer complaints, establishment of corrective and preventive actions (CAPA), and verification of effectiveness. Support for quality management of UDI, labeling, and PMS (post-manufacturing surveillance) data, and preparation of materials for overseas audits. Data Integrity and Traceability Check the integrity of batch records (BMR), test records, and computer logs (authority and audit trails). Operate a traceability system from raw materials to finished products to distribution, and conduct recall simulations. Customer and Sales Support Quality Data Provide a sales, bidding, and audit response package, including a Certificate of Assurance (CoA), Declaration of Conformity (DoC), ISO certification, and test results and validation summaries. Management of demo/exhibition sample management standards and records of recalls and inspections. KPI/Indicator Management Operate a dashboard for complaints rates, nonconformances/defects per million (PPM), delivery compliance, calibration and validation on-time rates, and CAPA lead times. Prepare monthly quality meeting materials and track improvement initiatives.

Qualifications

Required Requirements Bachelor's degree or higher: Preference will be given to a related major such as life sciences, bio/medical engineering, chemistry/chemical engineering, or industrial engineering. Document and regulatory understanding: Understanding of ISO 13485 and basic GMP concepts, and the ability to create, revise, and manage quality documents (basically Word, Excel, and PowerPoint). Collaboration and communication: Internal and external communication skills, including collaboration with development/production/RAs and audit response assistance. Basic English reading/writing: Ability to communicate with international standards/guidelines, CE/FDA documents, and emails is preferred.

Preferred

ISO 13485/GMP Training: Completion of basic practical/internal auditor training. Internal Auditor (Assistant) Competencies: Experience assisting in performing ISO 13485 internal audits or completion of a training course. Quality/Statistics Qualifications: Quality Management Engineer/Industrial Engineer, understanding of quality techniques such as Six Sigma and FMEA. Experience in Regulatory Collaboration: Assisting with documentation for the Ministry of Food and Drug Safety, CE, and FDA, and supporting technical documentation. Excel Skills: Ability to use functions and pivot tables necessary for data integrity checks, sampling, and defect indicator management.

Preferred Visas

Benefits