Quality Associate - Importer Hybrid Mid Day 1 HMO

• Salary: Day 1 HMO, Weekends Off
• Type: Full Time
• Region: International
• Town/City: Mandaluyong, National Capital Region
• Posted: 02/03/2026
• Listed in: Procurement / Supply Chain
• Reference: JOB-1772230013_1772457206
  
  

Job Description

Lead Quality Assurance for Industry-Defining Rehabilitation Solutions

Our client is a global leader in rehabilitation, recovery, and sports performance solutions, serving over 100 countries through more than 500 trusted partners. Backed by a 20,000-product portfolio and industry-defining brands such as THERABAND®, Rolyan®, Cramer®, and Jamar®, they power positive patient outcomes worldwide. Their commitment to innovation, regulatory excellence, and clinical credibility makes them a benchmark in global healthcare supply chains.

About The Role

As a Quality Associate - Importer, you will play a strategic role in safeguarding regulatory compliance and product integrity across global health markets. Your expertise directly protects patient outcomes, strengthens international supply chains, and ensures importer oversight meets the highest medical device standards. This is your opportunity to build a long-term global career with Emapta-where top 1% talent delivers a top 1% experience in a premium, stability-driven environment.

Job Overview

Employment Type: Full time

Shift: Mid shift, Weekends Off

Work Setup: Hybrid - Megatower, Ortigas

Exciting Perks Await!

• Day 1 HMO coverage with free dependent
• Competitive Salary Package
• 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) with a free physical fitness trainer!
• 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

• Bachelors degree in Engineering, Pharmaceutical Sciences, Life Sciences, or a related technical field
• 2 to 5 years of experience developing and defending complex regulatory submissions for medical devices or 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
• Strong analytical skills with keen attention to detail
• Eager to learn, adaptable, proactive, and mature in supporting business goals
• Excellent verbal and written communication skills
  
  

Preferred Qualifications

• ASQ or other relevant regulatory certification
• Experience interacting with EU, FDA, Health Canada, and other international regulatory bodies
• 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, trends, and improvement opportunities
• Support quality processes in accordance with ISO 13485, FDA QMSR, EU MDR Article 13, Health Canada, and other applicable global regulations
• Ensure implementation and maintenance of quality requirements
• Own and support CAPA processes, including root cause analysis, action plan development, action tracking, and long-term effectiveness verification
• Investigate nonconformances and customer complaints, drive containment actions, engage suppliers, and ensure timely resolution
• Collaborate with Engineering, Sourcing, Supply Chain, Manufacturing, R&D, and Production to resolve quality issues that affect product design, manufacturability, performance, timelines, or regulatory compliance
• Represent Quality in project and supplier meetings and communicate risks, quality concerns, and mitigation strategies clearly
• Conduct remote and onsite audits to assess compliance with GMP, ISO 13485, FDA QMSR, and other applicable regulatory standards
• Document audit findings, escalate risks, and verify corrective actions
• Participate in risk assessments and support risk management files in accordance with ISO 14971
• Maintain audit reports, incoming inspection records, supplier qualification files, change notifications, supplier scorecards, and quality or technical agreements in accordance with internal procedures and medical device regulations
• Review and assess supplier change notifications for regulatory and quality impact and ensure appropriate validation, documentation updates, and regulatory assessments
• Support internal and external audits by providing documentation, participating in interviews, and ensuring audit readiness and compliance
• Identify process weaknesses, recommend workflow improvements, and participate in cross-functional continuous improvement initiatives
  
  

KPIs - Importer Quality

• Achieve 100% importer documentation compliance with accurate, complete, and inspection-ready records
• Maintain zero critical or major findings attributable to importer documentation or supplier oversight gaps
• Review, assess, and document 100% of supplier change notifications within defined timelines
• Achieve at least 95% CAPA timeliness within defined due dates
• Maintain at least 95% CAPA effectiveness with no repeat issues
• Reduce supplier-related incoming quality defects by at least 10%
• Ensure 100% availability of supplier and importer records during audits
• Close all audit findings within defined timelines of 60 days based on severity
• Maintain zero supply interruptions attributable to supplier quality or importer compliance gaps
• Maintain zero launch delays attributable to supplier documentation, nonconformances, or CAPA execution
• Drive continuous reduction in issue resolution cycle time
  
  

Welcome to Emapta Philippines!

Join a team that values camaraderie, excellence, and growth. Recognized as one of HR Asias Great Places to Work 2025, Emapta stands proudly alongside industry giants, offering stability and exciting career opportunities. Your career flourishes here with competitive compensation, international clients, and a work culture focused on collaboration and innovation. Work with global clients across industries, supported by a stable foundation and like-minded professionals passionate about making an impact. We empower your success with opportunities for personal and professional development in an inclusive environment.

Apply now and be part of the #EmaptaEra!

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