Quality Assurance Staff Engineer

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

Driven by the passion to improve quality of people’s lives, WSA continues to grow as market leader in the hearing aid industry. With our commitment to increase penetration in an underserved hearing care market, we want to accelerate our business transformation in order to reach more people, more effectively.

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

What you will do

• 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.

What you bring

Experience

• 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 activities.




• Strong analytical, problem-solving, communication, and stakeholder management skills.




• Lead Auditor/Internal Auditor qualification is an advantage.

Personal competencies

• Analytical & problem-solving – able to identify quality issues and drive effective solutions.




• Quality-focused – meticulous with a strong eye for detail and compliance.




• Independent & systematic – able to work autonomously within structured processes.




• Collaborative – builds effective partnerships with R&D and cross-functional teams.




• Influential – able to provide objective quality guidance and challenge when required.




• Clear communicator – communicates quality risks and requirements effectively.




• Continuous improvement mindset – identifies opportunities to strengthen processes and product quality.

Who we are

At WSA, we provide innovative hearing aids and hearing health services.

Together with our 12,000 colleagues in 130 countries, we invite you to help unlock human potential by bringing back hearing for millions of people around the world.

With us, you will become part of a truly global company where we care for one another, welcome diversity and celebrate our successes.

Sounds wonderful?We can't wait to hear from you.

WSA is an equal-opportunity employer andcommitted to creating an inclusive employee experience for all. Regardless of race, color, religion, national origin, age, sex, gender, gender identity, gender expression, sexual orientation, marital status, medical condition, ancestry, disability, military or veteran status we firmly believe that our work is at its best when everyone feels free to be their most authentic self.