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Regulatory Compliance Specialist

3 weeks ago

Penang, Malaysia Boston Scientific Gruppe Full time

Our Commitment to Quality

We are committed to delivering high-quality medical solutions that improve patient health. As a Senior Quality Engineer, you will play a critical role in ensuring our products meet the highest standards of quality and safety.

Responsibilities:

  • Select appropriate problem-solving techniques and provide solid Engineering and Quality Assurance recommendations.
  • Read and interpret technical drawings, procedures, and protocols.
  • Makes decisions related to product quality, including disposing of non-conforming product.
  • Identify manufacturing process defects and assist in identifying primary root causes and understanding corrective actions.
  • Participate in Customer Complaints investigation for areas under your control.
  • Document investigation findings in analysis reports on GCS2.
  • Train others on software-related complaints handling processes (GCS2) as required.
  • Check and support the execution and investigation of CAPAs, NCEP, Failure Mode Investigations, etc.
  • Demonstrate and promote highest levels of professional QA engineering discipline and rigor.
  • Be a leader in QSR and ISO/MDD standards within your group, promoting awareness of best industry practices.
  • Have significant expertise in validation engineering and be familiar with regulatory requirements.
  • Review and approve operational, test, and validation data to establish technical specifications and performance standards for new products and processes.
  • Champion continuous improvement and innovation from a quality perspective.
  • Be an effective team member motivated to achieve best practices.
  • Provide technical guidance to Quality Engineers, Associate Quality Engineers, technicians, and inspection staff.
  • Work with EHS to identify environmental impacts and establish goals and targets.
  • Deal with suppliers, other engineering disciplines, and customers as needed.
  • Familiarize yourself with internal auditing processes.

Requirements:

  • Candidate must have a Bachelor's Degree in any Engineering course, Mathematics, Statistics, or Analytics or other Science-related courses.
  • At least 8-10 years of working experience in Quality System regulated organizations - ISO 9001/ISO 13485.
  • Experience in Distribution Quality/Operations Quality/Quality System will be advantageous.
  • Skill: Excellent influencing and communication skills, good team player, positive attitude, problem-solving skill, and leadership dependencies.
  • Working experience from a medical background will be advantageous.