SDM Japan Regulatory Service

Quality Management System Expert

We exist to create positive change for people and the planet. Join us and make a difference too!

Purpose of the Role

The role has responsibility for the delivery of assessment days required by the financial plan in a profitable way whilst ensuring that the standard of delivery continues to improve and puts the client first whilst maintaining our integrity. Recruiting, developing and managing a field based delivery team whilst managing and/or supporting a geographic territory. The role also includes mentoring in areas of competence to client managers, by developing and supporting a specialist field-based delivery team engaged in undertaking client assessment visits as determined by the agreed delivery plan. It is therefore essential that the role holder is a QMS expert with strong technical abilities in Medical Devices and its associated regulatory requirements.

Key Responsibilities & Accountabilities:

• Support the Associate/Regional Head of Assessment Delivery in establishing financial plans, monitoring performance and delivering to the required plans
• Manage delivery of the days required in the most efficient and cost-effective way, whilst minimizing carbon impact, ensuring delivery in line with business objectives and financial plan
• Ensuring the standard of delivery consistently meets client, scheme, regulatory and other requirements as applicable - inspection finding and CAPA
• Assist the Regional/Associate Head of Assessment Delivery with day to day Operations Management and Leadership
• Develop and cascade goals and objectives aligned to the Global QMS strategic objectives and in the context of BSI's mission, vision, values and behaviours
• Attract and retain key QMS talent, taking responsibility for their onboarding, training and ongoing development, as a coach and mentor ensure development plans are in place
• Monitor KPIs, goals and objectives, take action to address under performance monitor panel performance. (revenue days + panels)
• Work cross functionally across the business, ensuring impartiality requirements are complied with and problems resolved
• Foster a continuous improvement and performance driven culture, utilizing insights derived from data science and analysis studies, transferring best practice and lessons learnt across the organisation to improve the efficiency and effectiveness of the QMS operation, whilst ensuring quality of service
• Monitor client satisfaction for designated areas and ensure any complaints or queries are addressed in a timely manner, avoiding escalation where possible
• Ensure all team members follow BSI Policies, Procedures and systems
• Assist with staff audits and qualifying reviews as required - update procedure if need, for Liang to review and approve
• Undertake report reviews and analyse trends, taking action to address poor quality or regulatory risks
• Ensure compliance with Working Time requirements, local legal requirements, BSI policies and procedures, review and address issues raised
• Collaborate with other teams and regions to ensure overall success as one QMS
• Continually review team performance, identifying, developing and retaining key talent and addressing under performance as required

Key Performance Indicators

• Ensure team deliver the required audits, reports and other activities in accordance with the financial plan
• Ensuring the standard of delivery consistently meets the high level of client satisfaction required
• Support team to develop auditing competency according to targeted timeline
• Help to avoid client attrition by providing quality value added services and technical support
• Meet regulatory requirements and BSI requirements
• Support Business Improvement, Innovation and digital transformation

Travel Requirements:

Regular National and International Travel

Language Requirements:

Business English

Knowledge and Experience:

• Knowledge of conformity assessment procedures – most preferably in the medical device arena
• Knowledge of business processes and the application of quality management standards
• Regulatory or professional services experience
• Proven track record of effectively leading a virtual, technical and professional team across a regional of the globe
• Sound knowledge of financial planning and forecasting process
• Track record of driving improvements and successfully leading organizational change

Skills and Abilities:

• Translates business strategy and priorities into direction for self and others
• Establishes focus and agile individual, team and organizational goals that are aligned to RS goals and that will result in successful business performance
• Challenges the conventional way of doing things, generating new, innovative ideas and solutions and thinking outside the box
• Develops clear, structured, logical and efficient approaches to managing time, tasks, projects and workloads
• Makes timely and sound decisions and judgements even in the face of ambiguity
• Continually improving performance and driving the organization forward by identifying and seizing opportunities to do things more effectively
• Understands the key drivers of their team and selects appropriate leadership and management techniques to maximize their performance
• Creates a sense of interest and excitement about the business, its performance and its future aims and motivating individuals and teams towards achieving common goals and high performance
• Communicate with others clearly, concisely, confidently and in a way that engages the audience and achieves the desired result
• A genuine desire to cultivate learning and the development of others in building their skills and competencies through training, development, coaching and feedback, in order to meet their full potential, equipping them to meet the current and future needs of the business
• Working in partnership: seeks to establish and manage relationships with people who are instrumental in achieving business objectives, work co-operatively with peers and putting the goal of the team/department/business before personal goals
• Brings people with them through the challenges that change creates, helping them to embed lasting effective change, that is embraced and accepted across the business

Qualifications:

• Bachelor's degree in sciences, Engineering, or Business Administration, or equivalent relevant work experience in the professional services industry (e.g., management systems, consultancy services, medical devices).
• Proficiency in Business English required.

Personal Qualities / Aptitudes:

• Confidence and strength to operate at a senior business level as required
• In times of internal and external change as well as high growth expectations be an inspirational leader in order to motivate a large global team to go "the extra mile"
• Create a high performing, high value and motivational work environment for staff to thrive
• An empathetic leader that drives a positive and encouraging culture of teamwork

BSI Excellence Behaviours:

• Client Centric – I put internal and external clients at the centre of my thinking. I am proud to deliver outstanding client service.
• Collaboration – I build trust-based relationships through my ability to communicate openly and honestly. I value what others bring and I work inclusively with others at all times.
• Agility - I am open to change and willing to adapt my ways of working. I explore new ideas and ways to improve things to grow the business effectively.

Application accept time: till 15th. October. 2025

BSI is a business improvement and standards company and for over a century BSI has been recognized for having a positive impact on organizations and society, building trust and enhancing lives. Today BSI partners with more than 77,500 clients in 195 countries and engages with a 15,000 strong global community of experts, industry and consumer groups, organizations and governments. Utilizing its extensive expertise in key industry sectors - including automotive, aerospace, built environment, food and retail, and healthcare - BSI delivers on its purpose by helping its clients fulfil theirs. Living by our core values of Client-Centricity, Agility, and Collaboration, BSI provides organizations with the confidence to grow by partnering with them to tackle society's critical issues – from climate change to building trust in digital transformation and everything in between - to accelerate progress towards a better society and a sustainable world.

BSI is an Equal Opportunity Employer dedicated to fostering a diverse and inclusive workplace.