Quality Associate

Job Description

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 820.30.

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

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.