Boston Scientific Sr QA Specialist APAC 

South Korea, Yongin-si 

953987869

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 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.

• Leads the APAC internal audit process and programs.

• Develop, enhance and champion the quality awareness across all functions of the region.

• May supports 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.

• Takes a role in the management and preparation of the regional management review.

• Champions continuous improvement and innovation within the QA Dept. & 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/member in supporting quality disciplines, decisions, and practices.

• 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.

• 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.

Basic & Preferable Requirements

• 10+ years of experience in a QA related environment. Experience in the Medical Device or Pharma industry.

• Certified ISO 13485 auditor

• Good understanding of APAC countries regulatory requirements.

• Proven experience in a multi-national company with a matrix reporting structure.

• Solid understanding of quality management system with experiences

• 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.