Job Description

Location:

Pulau - , ,

Salary:

Competitive

Type:

Permanent

Main Industry:

Advertiser:

Job ID:

126499863

Posted On:

31 March 2023

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

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