Quality & Training Lead — ISO 13485 & Compliance

Manila HealthTek Inc.; Antipolo; On-site; PHP 650,000 - 800,000; Full time

Job summary

Manila HealthTek Inc. in Antipolo, Philippines, is seeking a capable Training Management & Quality Assurance Specialist to drive HR training delivery and ISO 9001/13485 compliance in a medical diagnostics manufacturing setting.

You will design training programs, implement QA controls, lead audits, and generate performance reports while maintaining records and ensuring safety and regulatory adherence.

Qualifications

• Minimum 3 years of direct experience in HR training management
• Experience in manufacturing with QA, auditing, and testing in a medical diagnostics-related industry
• Experience implementing ISO 9001, 13485 or similar management standards
• Solid knowledge of quality tools, process control, data analysis, statistics, and corrective action programs
• Strong command of organizational training methodologies, curriculum and syllabus development, instructional delivery, and documentation
• Advanced proficiency in Microsoft Excel, with working knowledge of Word, PowerPoint, Canva and Visio/Flowcharting software
• Excellent interpersonal skills, analytical capabilities, dependability, and self-motivation to execute duties with minimal supervision
• Bachelor's degree in relevant field and professional fluency in English and Filipino

Responsibilities

• Assess training needs, design and deliver training sessions, schedule sessions, manage budgets and logistics
• Define KPIs, collect and track data, monitor targets, analyze results, and generate reports
• Ensure policy and regulatory compliance, prepare reports, organize employee engagement activities, and update best practices
• Provide guidance on Quality Standards (ISO9001, ISO13485) implementation
• Provide Quality Audits scope, framework, and policies
• Monitor corrective actions
• Maintain and submit overall quality performance analysis reports
• Manage risk by ensuring compliance with policy, quality, safety, and operational standards
• Report any work hazards discovered in the workplace

Skills

Training management

Quality assurance

ISO 9001/13485

Data analysis

Curriculum development

Instructional delivery

Documentation

Analytical skills

Regulatory compliance

Education

Bachelor's degree in HR/BA/Engineering/Medical

Tools

Excel

Word

PowerPoint

Canva

Visio/Flowcharting

Job description

Manila HealthTek Inc. in Antipolo, Philippines, is seeking a capable Training Management & Quality Assurance Specialist to drive HR training delivery and ISO 9001/13485 compliance in a medical diagnostics manufacturing setting.

You will design training programs, implement QA controls, lead audits, and generate performance reports while maintaining records and ensuring safety and regulatory adherence.