Quality Assurance Specialist

1 day ago

Singapore beBeeQuality Full time $90,000 - $120,000

Job Overview:

We are seeking a highly skilled Quality Assurance Specialist to join our innovative team. The successful candidate will be responsible for ensuring the highest standards of quality and compliance are met for our medical devices.

  • Key Responsibilities:
  • Quality Management System: Develop, implement, and maintain a robust Quality Management System (QMS) compliant with FDA QSR, ISO 13485, and EU MDR regulations.
  • Risk Assessment: Conduct risk assessments (dFMEA, pFMEA) and failure mode and effects analysis to identify potential issues in device design and manufacturing.
  • Manufacturing Processes: Oversee validation and verification of manufacturing processes and equipment, ensuring design for manufacturability and product reliability.
  • Quality Control: Perform quality control inspections, reviewing specifications for raw materials, intermediate products, and finished devices per engineering drawings and SOPs.
  • Non-Conformance Investigations: Manage non-conformance investigations, root cause analysis, and corrective and preventive actions (CAPA) to address defects and ensure product safety.

Required Skills and Qualifications:

Candidate Profile:

  • Education: Bachelor's or Master's degree in Engineering (Mechanical, Biomedical, or related), Biology, Chemistry, or a related technical field.
  • Experience: Minimum 8 years of experience in quality assurance or regulatory affairs within the medical device industry, preferably with orthopedic devices.
  • Certifications: ASQ Certified Quality Engineer (CQE) or similar certification preferred.

Benefits:

Why Join Us:

  • Innovative Team: Be part of a fast-paced, innovative team advancing global orthopedic solutions that improve patient outcomes.
  • Competitive Salary: Enjoy a competitive salary and comprehensive benefits package.
  • Career Growth: Opportunities for career growth and professional development.

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