Certified Quality Professional

2 weeks ago

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

Job Title: Quality Assurance Specialist

Job Description:

The primary objective of this role is to ensure the adequacy and effectiveness of our quality management systems, while continuously striving for improvement.

  • Maintain and enhance quality management systems to meet regulatory requirements.
  • Collaborate with various departments to ensure awareness and understanding of the Quality Management System.
  • Plan and coordinate gap analysis exercises, providing guidance on bridging the gap.
  • Oversee quality audits by plan and ensure that quality audit findings and recommendations are addressed and implemented.
  • Inform management of quality audit findings and corrective actions taken.
  • Regularly review the Quality Management System to assess continued suitability and identify areas for potential improvement.
  • Arrange for ISO13485, ISO14971 and FDA 21 CFR Part 820 awareness training and additional refresher training as needed.
  • Ensure that systems and procedures are in compliance with ISO13485, ISO14971, FDA 21CFR Part 820, and GDP requirements.
  • Mentor/supervise as assigned and ensure timely and accurate completion of quality projects.
  • Support Plant-wide audit/inspection activities and special projects as assigned.
Required Skills & Qualifications:

This position requires a strong educational background and relevant work experience in quality management systems and manufacturing environments.

  • Bachelor's Degree in Quality Management or Electronics Engineering.
  • At least 3 years of working experience in Quality Management Systems, with a focus on manufacturing environments.
  • Excellent hands-on knowledge of Quality Management Systems primarily in ISO 13485 and FDA 21 CFR Part 820.
  • Strong leadership, mentorship, and problem-solving skills.
  • Ability to establish controls systems required in ISO13485 & FDA registered facilities.
  • Strong communication and interpersonal skills.
  • FDA Inspection experience is a plus.
Benefits:

This role offers an opportunity to work in a dynamic environment and contribute to the development of quality management systems.

We offer a competitive salary and benefits package, along with opportunities for professional growth and development.

Applicants should submit their resume and cover letter. We look forward to hearing from you.

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