Quality Associate

4 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

    6 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...

  • Food Quality Control Associate

    18 hours ago

    Manila, National Capital Region, Philippines Wonderfoods, Inc. Sizzling Plate Full time ₱400,000 - ₱800,000 per year

    Food Quality Control AssociateLocation: 5th Floor Tristar Bldg. Iran St. Brgy. Pinagkaisahan Makati City| Full-Time| Wonderfoods Inc. Sizzling PlateAre you passionate about ensuring high-quality standards in food production and maintaining safety protocols? Join our team as a Quality Control Associate and play a vital role in upholding the integrity and...

  • Quality and Compliance Specialist

    1 week 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 Assurance Associate

    17 hours ago

    Manila, National Capital Region, Philippines Asialink Finance Corporation Full time ₱150,000 - ₱250,000 per year

    Key Responsibilities:Conducting tests of all software applications.Identifying errors or issues during testing.Working closely with the development team to address any problems that arise.Send test documentation and error report to his or her superior.Key Requirements:Candidate must have a bachelor's degree in computer science, Information Technology,...

  • Sales Associate

    1 week 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...

  • Associate Attorney

    4 days ago

    Manila, National Capital Region, Philippines Mendoza Navarro-Mendoza & Partners Law Offices Full time ₱600,000 - ₱1,200,000 per year

    WE ARE AN ESTABLISHED LAW FIRM IN ORTIGAS CENTER PASIG CITY WITH DIVERSE LOCAL AND INTERNATIONAL CLIENTELE. WE HAVE GAINED A REPUTATION AS ONE OF THE BEST TRAINING GROUNDS FOR YOUNG LAWYERS. WE ARE DIFFERENT FROM A TRADITIONAL LAW FIRM IN THE WAY WE THINK AND WORK. WE URGENTLY NEED:LAWYERS (OR UNDER BAR ASSOCIATES)General Responsibilities:Participate in the...

  • Campaign Associate

    3 days ago

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

    Job SummaryThe Campaign Associate supports regional Campaign and Marketing Managers by executing email campaigns tailored to business targets. The role involves creating and activating assets in Eloqua while maintaining a sharp focus on quality assurance throughout the campaign lifecycle. By applying technical expertise and best practices, the Campaign...

  • Campaign Associate

    3 days ago

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

    Job SummaryThe Campaign Associate supports regional Campaign and Marketing Managers by executing email campaigns tailored to business targets. The role involves creating and activating assets in Eloqua while maintaining a sharp focus on quality assurance throughout the campaign lifecycle. By applying technical expertise and best practices, the Campaign...

  • Pharmacovigilance Associate

    2 weeks ago

    Manila, National Capital Region, Philippines ICON Strategic Solutions Full time $70,000 - $120,000 per year

    JR134842 Pharmacovigilance AssociateICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.We are currently seeking a Pharmacovigilance Associate to join...

  • Pharmacovigilance Associate

    2 weeks ago

    Manila, National Capital Region, Philippines ICON plc Full time ₱900,000 - ₱1,200,000 per year

    JR134847 Pharmacovigilance AssociateICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical developmentWe are currently seeking a Pharmacovigilance Associate to join our...