Senior Quality Manager, APAC

Work mode: Hybrid

Onsite Location(s):

Penang, SG

Purpose Statement:

The Senior Quality Manager APAC, is responsible managing the Quality Assurance activities and Quality Systems implementation to facilitate timely support to Boston Scientific country/regional business offices and customer service centers across the APAC region, ensuring the highest level of regulatory compliance in local operations. The role participates in and supports the Commercial Business Practices audit process to partner in driving best practice and internal/external compliance at the local level.

Responsibilities:

Lead and manage a team of Quality System Specialists and Managers responsible for overseeing quality system processes and compliance across the APAC region.
Act as the regional subject matter expert (SME) team for Quality Systems, supporting country affiliates and serving as the voice of APAC within the global Quality System process stewardship model.
Own and lead key APAC Quality System processes as the regional process owner, ensuring alignment with global standards and consistent execution across APAC markets.
Drive and manage regional quality governance forums (e.g., QMR, CRB, Process Forums, Community Calls, PMS), including content development, cadence, and effective stakeholder engagement.
Represent APAC in global quality system discussions, bringing strong expertise in critical quality processes such as CAPA, QMS, Post-Market Surveillance (PMS), and Distribution Quality while maintaining oversight of day-to-day operational execution.
Apply strong quality engineering and management fundamentals, including processes, tools, and practices commonly associated with Certified Quality Engineer/Manager frameworks.
Utilize a data-driven approach to quality management, leveraging analytics and statistical tools to identify quality signals, support decision-making, and drive continuous improvement.
Maintain working knowledge of APAC regulatory requirements for the Medical Device industry, ensuring regional compliance.

Requirements:

Minimum 12–15 years of experience in Quality Systems, preferably within the Medical Device industry and, or prior pharmaceutical regulatory exposure is considered an added advantage.
Proven APAC regional experience, with the ability to operate effectively in a complex matrix organization from MNCs.
Experienced people manager with at least 7 years of leadership experience, capable of providing both functional direction and developmental guidance to an APAC team.
Confident and vocal communicator with strong stakeholder management skills, able to influence, articulate viewpoints clearly, and appropriately escalate concerns or issues.
Strong understanding of Quality System requirements, with the ability to effectively partner with commercial teams and support business objectives.
Excellent communication skills, with the ability to represent the APAC region at a global level.

Requisition ID: 625733

As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.

So, choosing a career with Boston Scientific (NYSE: BSX) isn’t just business, it’s personal. And if you’re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!