Quality Assurance Professional

2 weeks ago

Singapore beBeeQuality Full time $80,000 - $120,000

Job Title:

Quality Assurance Professional

The Quality Assurance Specialist is responsible for ensuring the effectiveness of quality management systems and driving continuous improvement.

Key Responsibilities:

  • Maintain and enhance quality management systems to meet regulatory requirements.
  • Collaborate with various teams to ensure awareness and understanding of the Quality Management System.
  • Plan and coordinate gap analysis exercises, providing expert advice on bridging the gap.
  • Oversee quality audits by plan and ensure that quality audit findings and recommendations are addressed and implemented.
  • Communicate quality audit findings and corrective actions taken to management.
  • Review the Quality Management System periodically to assess its continued suitability and identify areas for improvement.
  • Arrange for ISO13485, ISO14971, and FDA 21 CFR Part 820 awareness training and refresher training as needed.
  • Ensure that systems and procedures are compliant with ISO13485, ISO14971, FDA 21 CFR Part 820, and GDP requirements.
  • Mentor and supervise team members, ensuring timely and accurate completion of quality projects.

Requirements:

  • Bachelor's Degree in Quality Management or Electronics Engineering.
  • At least 3 years of working experience in Quality Management Systems, preferably in a manufacturing environment.
  • Excellent hands-on knowledge of Quality Management Systems, primarily in ISO 13485 and FDA 21 CFR Part 820.
  • Strong leadership, mentoring, and problem-solving skills.
  • Establish and maintain controls systems required in an ISO13485 & FDA registered facility.
  • Excellent communication and interpersonal skills.
  • FDA Inspection experience is preferred.

What We Offer:

A competitive salary and benefits package, as well as opportunities for professional growth and development.

How to Apply:

Send your resume and cover letter to us. We look forward to hearing from you.

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