Quality Associate

3 days ago

Manila, National Capital Region, Philippines BruntWork Full time ₱1,200,000 - ₱2,400,000 per year

This is a remote position.

Schedule: Monday to Friday, 8:00 AM – 5:00 PM AEST
Total Weekly Hours: 40 Hours

Our client is seeking a Quality Associate to support and lead key elements of the Quality Management System (QMS), ensuring compliance with ISO 13485:2016, FDA 21 CFR Part 820, and EU MDR where applicable. This role involves oversight and preparation of documentation for design control activities, audit management, production quality, and post-market surveillance—helping to maintain the safety, performance, and regulatory compliance of Class II 510(k)-exempt medical devices.

Responsibilities

1. Quality System Support

  • Maintain, monitor, and improve the QMS in alignment with ISO 13485 and FDA QSR requirements under senior management supervision.

  • Lead document control activities, ensuring timely updates and controlled distribution of SOPs, work instructions, and forms.

  • Support internal and external audit preparations and participate during audits.

2. Design and Development Control

  • Support design and development activities per ISO 13485 and 21 CFR

  • Ensure Design History File (DHF), Medical Device File (MDF), and Device Master Record (DMR) documentation are accurate and current.

  • Assist with change control evaluations, assessing regulatory, risk, and compliance impacts.

3. Audit Management & Leadership

  • Support regulatory inspections (FDA, TGA, Notified Bodies) and serve as a point of contact.

  • Prepare audit reports, track corrective actions, and verify their closure to drive continuous improvement.

4. Production and Process Controls

  • Support process validation and verification activities (IQ/OQ/PQ).

  • Review and approve engineering change orders (ECOs) with proper risk and regulatory evaluations.

5. Nonconformance, CAPA, and Complaints

  • Investigate nonconformances, deviations, and customer complaints.

  • Support CAPA processes including root cause analysis and effectiveness verification.

  • Analyze quality metrics and trends to identify opportunities for preventive actions.

6. Regulatory and Compliance

  • Ensure labeling, packaging, and documentation meet FDA, ISO, and EU MDR requirements.

  • Monitor post-market surveillance including complaint handling and adverse event reporting.

  • Assess whether design or process changes require regulatory notification, ensuring compliance with 510(k)-exempt limitations.

Requirements

Education & Experience

  • Bachelor's degree in Life Sciences, Engineering, Quality, or related field (or equivalent experience).

  • 2–4 years of Quality Assurance experience in medical devices or regulated industries.

  • Experience with ISO 13485:2016, FDA 21 CFR 820, and ISO 14971 preferred.

  • Familiarity with design controls, risk management, and technical documentation.

Technical Competencies

  • Strong understanding of QMS principles and regulatory frameworks (ISO 13485, FDA QSR, EU MDR).

  • Knowledge of design control requirements, including DHF/MDF, DMR, and risk management.

  • Experience with CAPA, nonconformance management, and complaint handling.

  • Familiarity with Class II 510(k)-exempt device requirements.

  • Proficiency in QMS software and Microsoft Office Suite.

Behavioural Competencies

  • Excellent organizational skills with high attention to detail.

  • Strong analytical and problem-solving abilities.

  • Effective verbal and written communication skills.

  • Ability to work cross-functionally and build strong relationships.

  • Proactive, hands-on approach to continuous improvement and compliance.

Independent Contractor Perks

  • HMO coverage available for eligible locations

  • Permanent work-from-home arrangement

  • Immediate hiring

ZR_27537_JOB

  • Quality Associate I

    5 days ago

    Manila, National Capital Region, Philippines JPMorgan Chase Full time ₱1,200,000 - ₱2,400,000 per year

    Introducing the role of Quality Control Associate I – a pivotal position where your expertise will shape the future of our business operations. In this role, you will be at the forefront of maintaining a robust and disciplined control environment, ensuring that our processes are not only efficient but also sustainable. Your keen eye for detail and...

  • Distribution Quality Control Associate

    2 weeks ago

    Manila, National Capital Region, Philippines BandLab Technologies Full time ₱1,080,000 - ₱2,160,000 per year

    Distribution Quality Control Associate (3-months Contractor)Department: CommunityEmployment Type: TemporaryLocation: Manila, PhilippinesCompensation: ₱45,000 / monthDescription This is a 3-month contract position, with the possibility of extension or transition to a permanent role, depending on performance and business needs.For this role, applicants must...

  • Quality Assurance Analyst, Associate

    3 days ago

    Manila, National Capital Region, Philippines Infor Full time ₱1,500,000 - ₱3,000,000 per year

    & RequirementsThe Quality Assurance Analyst, Associate will be responsible for all testing phase of our production releases and all testing activities to ensure that the products meet the company standards. The Quality Assurance Associate requires documentation of all errors, identify the root cause, and provides suggestions for resolution, and regression...

  • Quality and Compliance Specialist

    7 days ago

    Manila, National Capital Region, Philippines RoyalCare Marketing Services, Inc Full time ₱900,000 - ₱1,200,000 per year

    Company DescriptionEstablished in 2008, RoyalCare, formerly known as Esguerra and Associates, has evolved into a full-service sales and marketing company known as MM RoyalCare Marketing Services, Inc. Under the leadership of Mr. Mario Meynard Esguerra Jr., RoyalCare is now the primary marketing arm of major insurance companies, serving 80,000 members across...

  • Quality Analyst

    2 weeks ago

    Manila, National Capital Region, Philippines Bill Gosling Outsourcing Full time ₱30,000 - ₱60,000 per year

    Join a Team That's Passionate About Making Lives BetterAt Bill Gosling Outsourcing, we believe that success starts with an amazing team. We are a global leader in outsourcing solutions, we focus on making lives better, one connection at a time. We provide tailored solutions to businesses around the globe, specializing in customer care, sales, and financial...

  • Quality Analyst

    3 days ago

    Manila, National Capital Region, Philippines Bill Gosling Outsourcing Full time ₱250,000 - ₱450,000 per year

    Join a Team That's Passionate About Making Lives BetterAt Bill Gosling Outsourcing, we believe that success starts with an amazing team. We are a global leader in outsourcing solutions, we focus on making lives better, one connection at a time. We provide tailored solutions to businesses around the globe, specializing in customer care, sales, and financial...

  • Associate & Senior Associate

    2 weeks ago

    Manila, National Capital Region, Philippines IDinsight Full time ₱40,000 - ₱80,000 per year

    About the Associate & Senior Associate roleIDinsight Associates and Senior Associates are high-performing early-career professionals passionate to experience the front-line realities of evidence-informed decision-making. These roles provide a rich, varied experience with responsibilities ranging from in-depth research and analysis, data collection...

  • Quality Assurance Associate

    1 day ago

    Manila, National Capital Region, Philippines Salmon Group Ltd Full time ₱20,000 - ₱25,000 per year

    Salmon – Who We Are and What We DoSalmonis a fast-growingconsumer fintech groupfounded inJuly 2022with the vision of creating thebest credit-led neobank in Southeast Asia. We launched first in thePhilippines, where we are now alicensed consumer-lending group, working towards aBSP banking license.OurCo-foundersare senior executives who previously...

  • Data Management Associate

    2 weeks ago

    Manila, National Capital Region, Philippines Allegis Global Solutions Full time ₱40,000 - ₱80,000 per year

    Company Description Working at Allegis Global Solutions (AGS) is more than just a job. It's a career. It's a community of people who invest in your development and empower you to blaze your own trail. Each of us is here to create real, measurable impact that moves needles. We operate beyond "roles" or "jobs" to realize the opportunity to make meaningful...

  • Sales Associate

    7 days ago

    Manila, National Capital Region, Philippines Fullerton Health PH Full time ₱600,000 - ₱1,200,000 per year

    Company DescriptionFullerton Health is a leading vertically integrated healthcare platform in Asia with a proven track record of providing enterprise healthcare solutions to clients and patients. Based at Bonifacio Stopover Corporate Center in Taguig City, Fullerton Health is dedicated to delivering quality healthcare services and solutions. The company is...