Certified Quality Assurance Professional

2 weeks ago

Singapore beBeeQualitySystem Full time $69,999 - $124,999

Job Description:

The Quality System Specialist plays a key role in supporting and performing activities associated with processes that make up the Quality Management System (QMS). Key responsibilities include managing change requests, ensuring timely reviews, and arranging meetings to discuss changes related to design, manufacturing processes, product design, and documentation. Collaboration occurs between internal stakeholders such as Manufacturing Engineering, Quality Control, and Value Engineering teams, as well as external stakeholders like R&D and Regulatory Affairs.

  • Change Request Process Management:

Review and manage change requests to ensure alignment with company policies and procedures. This includes collaborating with stakeholders to assess change impact and develop effective action plans.

CAPA Process Support:

Support Corrective and Preventive Action (CAPA) process owners in identifying root causes, developing action plans, executing corrective actions, and verifying effectiveness. Ensure timely closure of CAPAs.

Management Review Meetings:

Organize materials for periodic management review meetings according to ISO 13485:2016 standards. Coordinate logistics, scheduling, and follow-up actions to ensure effective decision-making.

Internal and External Audits:

Support internal and external audits/inspections by maintaining up-to-date documentation and records. Provide support during audit preparation and execution.

Requirements:

  • A Bachelor's degree or equivalent in a life science/technical discipline is preferred.
  • ISO 13485:2016 Lead Auditor certification is preferred.
  • At least 2+ years of experience in regulated manufacturing industries or an equivalent combination of education and experience.
  • Experience with QMS databases like Veeva and SAP is desired.
  • Understanding of GMP and quality system standards applicable to products manufactured by Bio-Rad is essential.
  • Strong communication and coordination skills across cross-functional and global teams are required.
  • Decision making, time management, organization, and computer skills are necessary.
  • Working knowledge of In-Vitro Diagnostic Device/Medical Device/Biotech manufacturing processes is beneficial.
  • Detail-oriented individuals who can multitask are preferred.

Benefits:

Join our team and be part of a dynamic and growing organization. As a Quality System Specialist, you will have opportunities to develop your skills, work with a diverse group of professionals, and contribute to the success of our company.

Others:

This is an excellent opportunity to advance your career in quality assurance and compliance. If you are a motivated individual looking for new challenges, apply now

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