BQ Lead Japan | WSA Japan

Driven by the passion to improve quality of people’s lives, WSA continues to grow as a 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 BQ Lead Japan is responsible for leading Quality and Regulatory activities across WSA Japan, ensuring compliance with the Japanese PMD Act, ISO 13485, and corporate requirements. The role oversees the local Quality Management System (QMS), regulatory compliance, product registration, audits, and quality assurance across manufacturing, sales, distribution, and wholesale operations in Japan.

As the Management Representative and Marketing Authorization Holder (MAH) for WSA Japan, the BQ Lead Japan plays a key role in ensuring regulatory and operational compliance and driving a strong quality culture across the organization.

What you will do

• Lead the implementation, maintenance, and continuous improvement of the local Quality Management System (QMS) in accordance with ISO 13485, the Japanese PMD Act, and corporate requirements

• Develop and implement country-specific quality strategies, plans, and actions to ensure operational and regulatory compliance across WSA Japan

• Oversee local regulatory compliance, including facility and product registrations, regulatory inspections, product approvals, certifications, and technical documentation and labeling requirements

• Act as Management Representative and Marketing Authorization Holder (MAH) for WSA Japan and serve as the authorized representative/signatory for applicable medical device regulatory matters

• Establish and oversee internal audit programs and coordinate external audits and inspections by regulatory authorities, customers, and notified bodies

• Ensure effective management of key QMS processes, including Document Control, Non-Conformance (NC), CAPA, Change Control, and Training

• Provide Quality support across manufacturing, sales, distribution, wholesale, and service operations, including product introduction, product transfers, product release, complaint management, and issue escalation

• Partner with cross-functional and global teams to identify quality risks, drive root cause analysis, and implement appropriate corrective and preventive actions

• Lead and develop the local BQ organization and contribute to quality and regulatory initiatives across the business

What you bring

• Significant experience in the medical device industry, with strong knowledge of Quality Management Systems and regulatory requirements

• Hands-on experience with ISO 13485, the Japanese PMD Act, product registration, and regulatory compliance

• Experience working with medical device regulatory authorities and managing regulatory inspections and audits

• Experience in Quality Assurance / Quality Management, preferably covering manufacturing, sales, distribution, and/or service operations

• Leadership experience with the ability to lead teams and influence stakeholders across functions

• A strong business- and customer-oriented mindset, with the ability to balance regulatory compliance with business needs

• QMS / ISO 13485 Auditor certification; Six Sigma certification or relevant knowledge is a plus

• University degree in Engineering or an equivalent field, with a background in Electronics preferred

• Native-level Japanese and advanced business-level English proficiency, with the ability to actively participate in APAC and global discussions

• A proactive, hands-on, and collaborative leader who takes ownership, communicates clearly, and is comfortable working in a complex, multinational environment

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.