Doc Con Engineer

Boston Scientific\'s hybrid workplace includes remote and onsite roles. By applying to this position, you will have the opportunity to discuss your preferred working location with your Talent Acquisition Specialist.



Remote Eligible: Onsite



Onsite Location(s): Pulau, Penang, MY





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

Job Segment: Medical Device, PLM, Medical Device Engineer, Document Control, Healthcare, Management, Engineering, Quality, Administrative