Work mode: Hybrid
Onsite Location(s):
Penang, MY
Additional Locations: N/A
Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance
At Boston Scientific, well give you the opportunity to harness all thats within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, well help you in advancing your skills and career. Here, youll be supported in progressing whatever your ambitions.
Purpose Statement
The role supports the Regional Director, Quality Systems, in developing, establishing, and maintaining quality systems and practices which meet BSC, customer and regulatory requirements. Develops, establishes and maintains quality-engineering methodologies, systems, and practices which meet BSC, customer, and regulatory requirements. Provide quality engineering support within technical development concepts, new product development, operational, or system/services support.
Key Responsibilities
Serves as a Quality representative to improve awareness, visibility, and communication on quality initiatives to support the assigned departmental, functional, regional and Global quality goals and priorities
Establishes the industry benchmark for Quality Systems best practice, determines robust, practical, compliant solutions for the business
Acts as regional subject matter expect for quality system processes, works closely with Subject Matter Experts (SMEs), the Manager, Quality Systems and the country affiliate teams, ensuring compliance with Boston Scientific Corporation policies / procedures and local regulatory requirements across the region
Lead the center of excellence team on centralized quality activities and processes
Develop, enhance and champion the quality awareness across all functions of the region
Support the SMEs and Manager, Quality Systems in maintaining a high level of control of the process documentation and associated training across the region
Leads system improvement teams selecting appropriate techniques for problem solving and process improvements
Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
Takes a role in the management and preparation of the regional management review
Lead the region on acquisition integration activities, working closely with global integration lead and work stream ensuring quality compliance during and after the transition of the acquisition into Boston Scientific quality system
Champions continuous improvement and innovation within the QA department and region. Manages and drives Value Improvement Projects across the region ensuring regional objectives are met
Collaborate and Liaises with the Global Quality Systems team and relevant working groups to drive continuous improvement
Act as team leader in supporting quality disciplines, decisions, and practices
Ensures the development and execution of streamlined business systems, which effectively identify and resolve quality issues
Advise management on potential improvements or enhancement to quality systems and processes in the company
Understands, interprets, and applies Documentation Control principles and processes to ensure compliance with Corporate, FDA, MDD, PAL, CMDCAS, ISO regulations and standards with unyielding integrity
Ensures awareness and compliance with applicable standard operating procedures to meet, comply and champion all quality and regulatory commitments of Boston Scientific
Qualifications
8+ years of experience in a QA related environment. Candidates with experience in the Medical Device or Pharma industry will be preferred
Supervisory experiences will be an added advantage
Proven experience in a multi-national company with a matrix reporting structure
Solid understanding of quality management system with experiences in the supplier quality management and/or post market surveillance processes
Knowledge on SAP and project management would be an added advantage
Pro-active, energetic, self-assured professional with ability to develop good interpersonal relationships with other entities of Boston Scientific
Excellent communication skills with the ability to positively influence key stakeholders without direct authority
Proficiency in Microsoft Excel, Word, and PowerPoint
Certifications in LEAN or Six Sigma will be a plus
Tenacity in following through on details
Fluency in English required; other language skills will be a plus
Requisition ID: 575511
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) isnt just business, its personal. And if youre 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!
Job Segment: Lean Six Sigma, Six Sigma, Compliance, Law, QA, Management, Legal, Quality
