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 Control Associate

    2 weeks ago

    Manila, National Capital Region, Philippines Wonderfoods, Inc. Sizzling Plate Full time

    Direct message the job poster from Wonderfoods, Inc. Sizzling PlateQuality Control Associate - Wonderfoods, Inc. Sizzling PlateLocation: 5th Floor Tristar Bldg. Iran St. Brgy. Pinagkaisahan Makati City • Employment type: Full-TimeAre you passionate about ensuring high-quality standards in food production and maintaining safety protocols? Join our team as a...

  • Quality & Audit Associate – Patient Safety

    1 week ago

    Manila, National Capital Region, Philippines ProductLife Group Full time

    About the RoleWe're looking for a detail-oriented professional to join our team as a Quality & Audit Associate – Patient Safety. In this role, you'll support our clients from the life sciences industry by ensuring quality standards are met across pharmacovigilance, medical information, and compliance activities. You'll work closely with both internal teams...

  • Associate & Senior Associate

    2 weeks ago

    Manila, National Capital Region, Philippines IDinsight Full time $70,000 - $120,000 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...

  • Wealth Management Credit Middle Office Quality Control Associate

    3 weeks ago

    Manila, National Capital Region, Philippines JPMorganChase Full time

    Wealth Management Credit Middle Office Quality Control AssociateUnlock your potential with J.P. Morgan, a global leader in financial services. Join our dynamic team and contribute to quality initiatives that drive excellence in credit operations.OverviewAs a Quality Control Associate in the Credit Quality Team, you will perform day-to-day quality reviews,...

  • Business Development Associate

    3 weeks ago

    Manila, National Capital Region, Philippines Six Sigma BELT Guru, Inc. Full time

    OverviewSix Sigma Belt Guru is a premier management consulting and training organization specializing in Lean Six Sigma, Quality Improvement, Continuous Improvement, Business/Operational Excellence, and Project Management. Our team of experts averages over 20 years of professional experience across various industries, including Manufacturing, Services, IT,...

  • Audit Quality Assurance Support

    2 weeks ago

    Manila, National Capital Region, Philippines Deloitte PLT Full time

    Select how often (in days) to receive an alert:Audit Quality Assurance Support - Senior AssociateDate: 28 Aug 2025Service Line / Portfolios: Business Operations/Office ServicesLocation: Jakarta, IDAudit Quality Assurance Support - Senior Associate: Audit Business Unit (based in Jakarta) – Senior AssociateAre you ready to unleash your potential?At Deloitte,...

  • Quality Analyst Specialist

    3 weeks ago

    Manila, National Capital Region, Philippines PartnerHero Full time

    Role DetailsContract Duration: Full-timeTraining Schedule: Monday - FridayWork Schedule: 10AM – 7PM Manila TimeWork Type and Location: Full Onsite, Taguig (McKinley)Expected Start Date: September 25, 2025About UsPartnerHero and Crescendo have joined forces to create a powerhouse of innovation, excellence, and people-first solutions. By combining...

  • Content Quality Assurance Specialist

    2 weeks ago

    Manila, National Capital Region, Philippines beBeeReviewer Full time ₱45,000 - ₱55,000

    Editorial Reviewer PositionWe are seeking an Editorial Reviewer to perform quality assurance checks on edited manuscripts and provide timely feedback to our team.The ideal candidate will have a PhD/Master's/Bachelor's degree in the required subject area, excellent English proficiency, and attention to detail.Perform quality assurance checks on edited...

  • Business Development Associate

    2 weeks ago

    Manila, National Capital Region, Philippines beBeeDevelopment Full time ₱600,000 - ₱1,000,000

    Job Title: Business Development AssociateJob DescriptionWe are seeking a highly detail-oriented and organized Business Development Associate to manage cold outreach efforts and drive new business opportunities.The ideal candidate will have strong organizational and time management skills, with the ability to manage multiple outreach campaigns...

  • Fund Servicing Associate I

    4 weeks ago

    Manila, National Capital Region, Philippines JPMorganChase Full time

    Join to apply for the Fund Servicing Associate I role at JPMorganChase 3 days ago Be among the first 25 applicants Join to apply for the Fund Servicing Associate I role at JPMorganChase Get AI-powered advice on this job and more exclusive features. Job DescriptionBe a part of JPMorgan Chase Commercial and Investment Banking as a Fund Servicing...