Job Description

Recruiter: Jason Tan

Purpose Statement

Establish and support a work environment of continuous improvement that supports BSC\xe2\x80\x99s Quality Policy, Quality System, and the appropriate regulations for the area.

Roles & Responsibilities

• Efficiently organize, plan and lead Document Control activities.
• Subject Matter Expert (SME) for Product Lifecycle Management (PLM) System.
• Train employees on PLM System.
• Create new or revised documents related to Document Control and route for approval.
• Tracks progress in obtaining approvals.
• Review, evaluate, approve and recommend changes to local procedures and other documents related to assuring compliance with Corporate and ISO requirements.
• Manages the biennial review of documentation system to ensure compliance to standards Suggests changes to processes documentation and training programs in the spirit of continuous improvement.
• Assist in global conference calls and documentation process meetings.
• Interacts between functional groups regard Document Change Notices.
• Facilitates Document Review meeting and makes recommendations as needed to functional areas.
• Monitors and documents compliance with the local training program to ensure training compliance.
• Support back office during external audit/inspection.
• Supports implementation of quality initiatives.
• Identifies quality system problems, while providing advice and solutions, verifying ultimate implementations of those solutions.
• Supports teams in implementation of quality systems upgrades.
• Give support to the Area Manager and/or Supervisor when it is required.
• Update supervisor of work status or problems with recommendations for improvement or correction.
• Perform SAP transactions in PLM as required.

Requirements :

• minimum 4 years of experience in a Quality systems related environment. Candidates with experience in the Medical Device or Pharma industry will be added advantages.
• Solid understanding of quality management system and certified in Quality system ISO 13485
• Proven experience in a multi-national company with a matrix reporting structure
• Good understanding of regulatory requirements especially for medical devices.Excellent communication skills with the ability to positively influence key stakeholders without direct authority
• Good inter-personal skills. Strong quality mindset. Ability to manage conflicting situations. Ability to embrace ambiguity. Good leadership skills.

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.

Requisition ID: 561597

Boston Scientific