Head of Quality Assurance - R&D

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 and committed 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.