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Senior Quality System Engineer 1

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]]
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.

Purpose Statement

Develops, establishes and maintains quality engineering methodologies, systems, and practices which meet BSC, customer, and regulatory requirements. Understands and complies with all the regulations governing the quality systems. Create processes and process improvements to ensure consistent implementation of internal requirements and external laws, regulations, guidance and standards. Act as a SME on the CAPA System, Internal and External Audit process, Supplier Management and supporting customized Complaint Management System. Serves as a Quality representative to improve awareness, visibility, and communication on quality initiatives to support departmental, functional, site, divisional and corporate quality goals and priorities.

Key Responsibilities

  • Implementation of internal requirements and external laws, regulations, guidance and standards as applicable to Boston Scientific quality systems.
  • 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 ISO, MDD, other applicable standard requirements and internal requirements. To include audit scheduling, investigation, and evaluation of audit observation and findings.
  • Identify areas of potential noncompliance or improvements by managing and conducting internal audits per schedule.
  • Lead the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements.
  • Support the site corrective and preventive actions process.
  • Collect and analyze business/quality system process data from team members of Penang Trading.
  • Gather site quality metrics, prepare the management review presentation materials.
  • Coordinate, present the metrics and material at site management review.
  • Create management review meeting minutes, attendance list and ensure proper documentation of management review materials in accordance to Boston Scientific procedures.   
  • Plan, coordinate and develop enhancement to existing customized complaint management system for OEM-supplied products (OCS).
  • Ensure the robust functionality and performance of OCS and its geo-expansion to non-Japan countries.  
  • Identifies, Supports and Leads Material Value Improvement Projects (VIP’s) throughout the Supply Chain.
  • Assess potential new suppliers for technical, quality and manufacturing capabilities. Provides technical support for the introduction of components and sourced finished devices from a new supplier.
  • Assists in generating component or sourced finished device specifications.
  • Generate test protocols, monitor testing, issue qualification test reports and approve components for use in products or sourced finished devices for distribution.
  • Support the management of suppliers.
  • Lead and support supplier audits. May require travelling to support on-site supplier audit.

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: 539509

Job Segment: Senior Quality Engineer, Systems Engineer, Quality Engineer, Manufacturing Engineer, CAPA, Engineering, Management

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