Job Description

Purpose and Passion \xe2\x80\xa2 Comprehensive Benefits \xe2\x80\xa2 Life-Work Integration \xe2\x80\xa2 Community \xe2\x80\xa2 Career Growth

At Boston Scientific, you will find a collaborative culture driven by a passion for innovation that keeps us connected on the most essential level. With determination, imagination and a deep caring for human life, we\xe2\x80\x99re solving some of the most important healthcare industry challenges. Together, we\xe2\x80\x99re one global team committed to making a difference in people\xe2\x80\x99s lives around the world. This is a place where you can find a career with meaningful purpose -- improving lives through your life\xe2\x80\x99s work.

Onsite Location(s):

Penang DC, Malaysia

Hiring Manager: Rachel Chong

Recruiter: Jason Tan

About the role:

The Senior Manager leads a team of DC Quality Operations at Penang Distribution Center consisting of Senior Engineers, Engineers, Technicians and ensures the Quality System is substantially compliant to GMP/QSR practices/standards, ISO/MDSAP and applicable local regulatory requirements. This role serves as the delegate of Penang DC Head of Quality supporting and/or in conjunction with the Quality Director, for the following responsibilities:

Key responsibilities:

• In all actions, demonstrating a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
• Providing leadership and direction to their team and ensure a Quality Management System exists to meet the various requirements of a medical device organization. Specifically, they will ensure the necessary monitoring of Identification & Traceability, Production (e.g., localization) and Finished Goods Acceptance, Handling and Distribution Controls, including product release and systems which impact the distribution centers and supply chain.
• Building a strong and sustaining relationship with the Supply Chain organization, Countries QA/Regulatory in Asia Pacific, external Regulatory bodies and others and will be recognized as an excellent team player within the total organization on site.
• Developing and monitoring department budgets and determine appropriate staff levels, schedules, and resources.
• Being committed to developing people and is recognized as an expert in mentoring and coaching individual and team performance while visibly demonstrating the core values of BSC in their everyday leadership style.
• Continuously foster and driving a continuous improvement approach to Quality on Site ensuring that quality is the responsibility of everyone - not just the QA department and that the Quality System is an integrated and integral aspect of the total running of the Site.
• Serving as delegate to Quality Management Representatives and help to oversee distribution activities through maintenance of Good Distribution Practice of Medical Device (GDPMD) establishment licensing with local authority.

What we\'re looking for in you:
Minimum requirements

• B.S. Degree with minimum of 12+ years\xe2\x80\x99 experience in quality for medical devices, pharmaceuticals or other suitable discipline.

• 5+ years of direct managerial experience across a matrixed organization.
• 1-2% travel required.

Additional skillsets:

• Comprehensive understanding of the QSR, cGMP and ISO/MDD standards.
• Excellent communication skills with the ability to influence others.
• High level of initiative & autonomy through continuous questioning of current practices.
• Effective team member, motivated to achieve and demonstrate best practices in line with the department & global objectives
• Experience with problem solving quality tools.
• Fluent in English

About Us

As a global medical technology leader for more than 35 years, our mission at Boston Scientific (NYSE: BSX) is to transform lives through innovative medical solutions that improve the health of patients. If you\xe2\x80\x99re looking to truly make a difference to people both around the world and around the corner, there\xe2\x80\x99s no better place to make it happen

Boston Scientific