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Senior Quality System 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

Location: [[city]], [[stateProvince]], [[country]]
Additional Locations: Malaysia-Penang
Hiring Manager: [[hiringManagerName]]
Recruiter:
Jason Tan

 

Purpose Statement

Establish and support a work environment of continuous improvement that supports BSC’s Quality Policy, Quality System, and the appropriate regulations for the area.

Key Responsibilities

  • Responsible for the implementation, co-ordination and continuous review of the CAPA, Internal and Corporate Compliance programs in Boston Scientific Penang.
  • Has expertise in internal auditing techniques and is familiar with all regulatory requirements (e.g., FDA, ISO and MDD).
  • Plan, coordinate and conduct scheduled audits to assess compliance with FDA, ISO, MDD, other applicable standard requirements and internal requirements. To include audit scheduling, investigation, and evaluation of audit observation and findings.
  • Provide guidance for Auditors as necessary.
  • Manage and/or support audit frontroom and backroom activities during external audits
  • Responsible for conducting, and confirming follow-up actions on Corporate/Divisional/Site Compliance Audits
  • Attend global conference calls and meetings related to the internal audit process and etc.
  • Drives changes in procedures and standards to facilitate work efficiency and to maintain quality.
  • Facilitation of CAPA management in other area of the organization.
  • Conduct Quality System Training to BSC Penang employees.
  • To lead system improvement teams using a variety of different methodologies and selecting appropriate techniques for problem solving and process improvements.

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’re looking to truly make a difference to people both around the world and around the corner, there’s no better place to make it happen.

Requisition ID: 549137


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