Hardware QA Lead - Regulatory-Driven Excellence

WSAudiology; Singapore; On-site; SGD 120,000 - 160,000; Full time

Job summary

WSAudiology in Singapore seeks a Quality Assurance Staff Engineer to act as an independent quality partner for hardware development projects, ensuring products meet quality, safety, regulatory, and risk management requirements. The role covers hearing aids, chargers, accessories, and other hardware products throughout the product lifecycle, from development through design transfer and maintenance.

The position emphasizes collaboration with R&D, regulatory teams, and suppliers, driving continuous

Qualifications

• Bachelor's degree in engineering, Biomedical Engineering, Electronics, Mechanical Engineering, Quality Management, or related field.
• 8+ years of experience in Quality Assurance, Product Development, Design Quality, or Regulatory Affairs.
• Experience supporting hardware development projects, preferably in a regulated environment.
• Knowledge of design controls, risk management, quality systems, and product lifecycle management.
• Experience with supplier qualification and manufacturing transfer.
• Strong analytical, problem-solving, communication, and stakeholder management skills.
• Lead Auditor/Internal Auditor qualification is an advantage.

Responsibilities

• Act as the Quality representative in hardware development projects and provide quality guidance throughout the product lifecycle.
• Ensure compliance with design controls, quality systems, risk management, and regulatory requirements.
• Review design deliverables, test records, design inputs/outputs, reviews, verification, validation, and design transfer documentation.
• Review verification and validation strategies, protocols, and reports and support resolution of findings.
• Participate in design reviews, phase-gate assessments, and release readiness activities.
• Support regulatory compliance, technical documentation, and internal/external audits and FDA inspections.
• Drive continuous improvement through process improvements, lessons learned, and product/field feedback.

Skills

Quality Assurance

Product Development

Design Quality

Regulatory Affairs

Supplier Qualification

Manufacturing Transfer

Analytical Thinking

Stakeholder Management

Lead Auditor

Internal Auditor

Education

Bachelor's degree in engineering

Biomedical Engineering

Electronics

Mechanical Engineering

Quality Management

Job description

WSAudiology in Singapore seeks a Quality Assurance Staff Engineer to act as an independent quality partner for hardware development projects, ensuring products meet quality, safety, regulatory, and risk management requirements. The role covers hearing aids, chargers, accessories, and other hardware products throughout the product lifecycle, from development through design transfer and maintenance.

The position emphasizes collaboration with R&D, regulatory teams, and suppliers, driving continuous