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QA Specialist / Senior Specialist (2 year contract)

Work mode:  Hybrid
Onsite Location(s): 

Penang, MY

 

Additional Locations:  N/A

 

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

At Boston Scientific, we’ll give you the opportunity to harness all that’s 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, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.

 

Purpose Statement

This role supports/execute/implement all activities as driven by the restructuring program Synapsis. The role is expected to understand all quality processes in scope of the program, optimization and building efficient centralized processes in accordance with Boston Scientific (BSC) Quality Systems. This includes 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.

 

Roles & Responsibilities

  • Serves as a Quality representative to improve awareness, visibility, and communication on quality initiatives to support assigned departmental, functional, regional and Global quality goals and priorities
  • Establishing procedures for operational execution of centralized quality activities ensuring quality conformity to BSC quality systems
  • Execute day-to-day activities when the centralized quality processes are operationally ready to be used
  • Act as the point of contact on requests from affiliates, supporting and providing the required data or information
  • May support SME 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
  • Collaborate and liaises with the APAC Quality Systems team and relevant working groups to drive continuous improvement
  • Assure 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
  • Ensures awareness and compliance with applicable standard operating procedures to meet, comply and champion all quality and regulatory commitments of BSC

 

Qualifications

  • 3-5 years of experience in a QA related environment. Candidates with experience in the Medical Device or Pharma industry will be preferred
  • Proven experience in a multi-national company with a matrix reporting structure
  • 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 BSC
  • Good communication skills with the ability to positively influence key stakeholders without direct authority
  • Proficiency in Microsoft Excel, Word, and PowerPoint
  • Tenacity in following through on details

 

Requisition ID: 580479

 

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!

 


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