QA Specialist

[Purpose Statement]

The purpose of this role is to provide Quality and Regulatory expertise to support the local/region/international business objectives as well as provide guidance to employees to facilitate continuous quality improvement. The primary role is to ensure compliance with Quality System activities (programs, policies, processes, procedures) to achieve stated objectives. 

[Key Responsibilties]

• Maintain, advice and report on compliance to Corporate Quality System, International and Local Requirements and Regulations as well as Quality Policies and Procedures to site Management Team and other employees on how to achieve compliance for the Quality System elements, as applicable to the site

• Promote and develop quality awareness in every employee, while helping the site organization towards improved quality performance and ownership as well as customer and regulatory/compliance-oriented initiatives

• Monitor, identify and report on key Quality System indicators and takes appropriate action to address areas for improvement

• May verify implementation of suggested solutions; be responsible for continuous Quality System efficiency and effectiveness and promoting solution-driven behavior; Frequently interact with and represent the quality function to certain BSC departments like Operations, Regulatory, Sales and others, as key Quality System processes are managed by those areas (e.g. Complaint reporting, Field Action execution, etc)

• May interact with national regulatory authorities; In all actions, demonstrate a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures

• Support and lead activities related to QMS, PMS, KGMP, Quality Projects for continuous improvements

[Qualifications]

• 2-3 years of experience in a QA related environment. Candidates with experience in the Medical Device or Pharma industry will be preferred

• 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 Boston Scientific

• 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

• Fluency in English required; other language (Korean and Japanese) skills will be highly desired

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