Head of Quality Assurance – R&D

5 days ago

Singapore WS Audiology Full time

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. We are seeking an experienced and proactive Head of Quality Assurance for R&D to lead Quality Assurance and Compliance activities together with our R&D organization. This role is critical in ensuring that our hearing aid products — increasingly focused on software, firmware, and Software as a Medical Device (SaMD) — are developed in compliance with regulatory requirements and meet the highest standards of quality and reliability. The ideal candidate will be a strong partner to R&D, Marketing, Operations providing expert guidance on verification and validation (V&V) strategies, quality planning, and risk management throughout the product development lifecycle. What you will do Lead and manage Quality Assurance activities across all R&D projects, with a focus on software, firmware, and SaMD. Act as the primary quality partner for R&D and Marketing teams, ensuring alignment on quality expectations and compliance requirements. Develop, review, and approve V&V strategies, protocols, and reports to ensure robust product performance and regulatory readiness. Ensure compliance with applicable global regulatory standards (e.g., FDA, MDR, ISO 13485, IEC 62304, IEC 60601, ISO 14971). Drive continuous improvement in design control processes, including risk management, design verification, validation, and traceability. Support internal and external audits related to R&D and product development. Collaborate with cross-functional teams to ensure timely and compliant product launches. Provide leadership, coaching, and development to QA team members supporting R&D. What you bring Bachelor’s or Master’s degree in Engineering, Life Sciences, or a related field. Minimum 8 years of experience in Quality Assurance within the medical device industry, preferably with a focus on software-based products. Strong knowledge of design controls, V&V, and regulatory requirements for medical devices and SaMD. Experience working in cross-functional teams and influencing without direct authority. Excellent communication and collaboration skills. Proven ability to work in a global, matrixed organization. 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. #J-18808-Ljbffr

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