Global Innovator in Rehabilitation and Wellness Solutions
Our client is a leading global manufacturer and distributor of rehabilitation, recovery, and performance products trusted by healthcare professionals in over 100 countries. With decades of industry leadership, an ISO-certified quality culture, and a portfolio of internationally recognized brands, they continue expanding into regulated markets worldwide. Joining their team means contributing to products that improve mobility, recovery, and quality of life-while operating within world-class quality and compliance standards that shape global healthcare outcomes.
Job Description
As a Quality Associate - Supplier, you support and maintain compliance under an ISO 13485-certified Quality Management System. You ensure finished medical devices, OTC drugs, cosmetics, and consumer products meet global regulatory and safety standards, while partnering cross-functionally to mitigate risk and improve supplier performance.
Your expertise directly reduces defects, strengthens supplier capability, and safeguards regulatory compliance across markets. With Emapta, you gain global exposure, structured development, and a top 1% professional experience built for high-performing quality specialists.
Job Overview
Employment type: Full time
Shift: Night shift, Weekends Off
Work setup: Hybrid, Megatower, Ortigas
Exciting Perks Await!
- Day 1 HMO coverage with free dependent
- Competitive Salary Package
- Night differential pay to maximize your earnings
- Hybrid work arrangement
- Prime office location in Ortigas (Easy access to MRT stations, restaurants, and banks)
- Fixed weekends off
- Salary Advance Program through our banking partner (Eligibility and approval subject to bank assessment. Available to account holders with minimum of 6 months company tenure.)
- Unlimited upskilling through Emapta Academy courses (Want to know more Visit: https://emapta.com/training-calendar/)
- Free 24/7 access to our office gyms (Ortigas and Makati)
- Exclusive Emapta Lifestyle perks (hotel and restaurant discounts, and more!)
- Unlimited opportunities for employee referral incentives across the organization
- Standard government and Emapta benefits
- Total of 20 annual leaves to be used on your own discretion (including 5 credits convertible to cash)
- Fun engagement activities for employees
- Mentorship and exposure to global leaders and teams
- Career growth opportunities
- Diverse and supportive work environment
The Qualifications We Seek
- Bachelor's degree in Engineering, Pharmaceutical, Life Sciences, or other related technical field
- 2 to 5 years of experience developing and successfully defending complex regulatory submissions for medical devices and drugs
- Experience providing administrative support and managing communications (including calls) for international clients in the EU, US, Canada, and other regions
- Proficiency in Microsoft Excel and data analysis tools
- Highly analytical with strong attention to detail
- Eager to learn, adaptable, takes initiative, and aligned with business goals
- Excellent communication skills, both verbal and written
Preferred Qualifications
- ASQ or other regulatory certification
- Ability to self-motivate and drive results
- Experience effectively interacting with EU, FDA, and other international regulatory bodies including Health Canada
- Project management experience
- Professional regulatory affiliations such as RAPS
Your Daily Tasks
- Analyze quality data, incoming inspection results, nonconformance trends, audit findings, and quality metrics to identify risks and opportunities for improvement
- Support quality responsibilities in accordance with ISO 13485 and applicable regulatory requirements (e.g., FDA QMSR, EU MDR Article 13, Health Canada, and other global regulations as applicable)
- Ensure quality requirements are implemented and maintained
- Own and support corrective and preventive actions (CAPA), including root cause analysis, development and tracking of action plans, and verification of long-term effectiveness
- Investigate nonconformances and customer complaints, driving containment, supplier engagement, and timely resolution
- Collaborate cross-functionally with Engineering, Sourcing, Supply Chain, Manufacturing, R&D, and Production to resolve quality issues impacting product design, manufacturability, performance, timelines, or regulatory compliance
- Represent Quality in project and supplier meetings, clearly communicating risks, concerns, and mitigation strategies
- Conduct audits (remote and on site) to assess compliance with GMP, ISO 13485, FDA QMSR, and other applicable regulatory standards
- Participate in risk assessments and support risk management files in accordance with ISO 14971
- Maintain quality documentation and records including audit reports, inspection records, supplier qualification files, change notifications, scorecards, and quality agreements
- Review and assess change notifications (PCNs) for regulatory and quality impact
- Support internal and external audits by providing documentation and ensuring audit readiness
- Drive continuous improvement by identifying process weaknesses and recommending stronger quality workflows
KPIs - Quality Associate - Supplier Quality
- Supplier CAPA Timeliness: Responses and action plans within 30 days
- CAPA Effectiveness: 95% with no recurrence
- Supplier Nonconformance Closure Time: 45 days average
- On Time Supplier Qualification: 100% completed by project milestones
- Quality Related Launch Delays: Minimal delays attributable to supplier quality
- Issue Resolution Cycle Time: Continuous reduction
- On Time Supplier Audits: 95% completed as scheduled
- Audit Finding Closure: 60 days based on severity
- Supply Outcomes: No major supplier-related delays
- Documentation Compliance: 100% accurate and on time
KPIs - Quality Associate - Importer Quality
- Importer Documentation Compliance: 100% accurate, complete, and inspection-ready
- Regulatory Inspection Readiness: Zero critical or major findings attributable to documentation gaps
- Change Notification Timeliness: 100% reviewed and documented within defined timelines
- CAPA Timeliness: 95% closed within due dates
- CAPA Effectiveness: 95% effectiveness rate with no repeat issues
- Incoming Quality Issues: 10% reduction in supplier-related defects
- Audit Readiness: 100% availability of requested records
- Audit Finding Closure: All findings closed within 60 days (severity-based)
- Audit Support Effectiveness: No repeat findings related to importer or supplier controls
- Quality Related Supply Disruptions: Zero interruptions attributable to supplier quality gaps
- Quality Related Launch Delays: Zero delays attributable to supplier documentation or CAPA execution
- Issue Resolution Cycle Time: Continuous reduction through proactive management
Other Job Duties and Responsibilities
- Perform other duties as assigned
Welcome to Emapta Philippines!
Be part of a workplace that values excellence, collaboration, and growth. Recognized as one of HR Asia's Best Companies to Work For in Asia 2025, Emapta stands proudly alongside industry leaders, offering stability and exciting global career opportunities. Work with international clients while enjoying competitive compensation and a culture built on innovation and support. Grow professionally and personally in an inclusive environment designed to help you thrive.
Apply now and be part of the #EmaptaEra!
