Senior Hardware QA & Compliance Engineer

WSA – Wonderful Sound for All

Singapore

On-site

SGD 120,000 - 180,000

Full time

7 hours ago

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Job summary

WSA – Wonderful Sound for All is seeking a Quality Assurance Staff Engineer to act as the quality partner for hardware development, ensuring products meet quality, safety, and regulatory requirements. You will oversee the lifecycle of hearing aids, chargers, and accessories from development through transfer and maintenance.

Ideal candidates have 8+ years in QA or related fields, with strong knowledge of design controls, risk management, and regulatory affairs.

Qualifications

Bachelor's degree in engineering, biomedical, electronics, or related field.
8+ years in QA, product development, design quality, or regulatory affairs.
Experience with hardware development in regulated environments.
Knowledge of design controls, risk management and product lifecycle.
Supplier qualification and manufacturing transfer experience.
Auditing: Lead Auditor/Internal Auditor is a plus.
Strong analytical and communication skills.

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.