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Senior Quality System Engineer

2 months ago

Malaysia Boston Scientific Full time

Quality Assurance & Control (Manufacturing, Transport & Logistics)

Full-time position at Boston Scientific

Develops, establishes, and maintains quality engineering methodologies, systems, and practices that meet regulatory requirements and company standards.

Key Responsibilities:

  • Implement quality systems and processes that meet regulatory requirements and company standards.
  • Lead and support site external inspections and audits.
  • Plan, coordinate, and conduct scheduled audits to assess compliance with regulatory requirements.
  • Identify areas of potential noncompliance or improvements through internal audits.
  • Lead the implementation of assurances, process controls, and CAPA systems.
  • Support the site corrective and preventive actions process.
  • Maintain the CAPA process and develop and distribute CAPA metrics.
  • Educate functional areas on quality system requirements.
  • Participate in cross-functional teams to standardize quality system policies and procedures.
  • Travel to support business or other sites as needed.

Requirements:

  • Bachelor's degree in Science or Engineering.
  • At least 8-10 years of working experience in a related field.
  • Experience in Medical Devices Manufacturing Industry is an advantage.
  • Internal and external audit experience.
  • Non-conforming event and CAPA experience.
  • Management Review experience.
  • Knowledge of ISO13485, EU MDR, FDA Regulations, cGMP, and Combination Device Regulations.