Quality System Specialist Role at Bio-Rad | BS Life Science Graduates Apply Now
Bio-Rad, a global leader in life sciences and clinical diagnostics, is hiring a Quality System Specialist II in Singapore (Job ID: 2025-37197). This role presents an excellent opportunity to contribute to the company’s Quality Management System (QMS), ensuring compliance with global standards such as ISO 13485:2016 and MDSAP. If you are detail-oriented with experience in regulated manufacturing industries, this position could be the next step in your career.
- Job Position: Quality Sys Spec II
- Location: Singapore
- Job ID: 2025-37197
About the Company:
For over 70 years, Bio-Rad has been advancing scientific discovery and healthcare through innovative life science research and clinical diagnostic products. Recognized as one of the top five life science companies worldwide, Bio-Rad empowers scientists and healthcare providers with solutions that improve lives globally. With a strong culture of innovation, inclusivity, and collaboration, Bio-Rad offers its employees opportunities to grow while making a meaningful impact.
Job Description:
The Quality System Specialist II will play a key role in supporting Bio-Rad’s Quality Management System (QMS) processes, ensuring compliance with global regulatory frameworks and standards. The role involves managing change requests, CAPA processes, audits, and management review meetings, while collaborating with cross-functional and international teams.
Key Responsibilities:
- Manage the change request process, ensuring timely reviews and meetings for changes related to product design, documentation, and manufacturing processes.
- Support and co-manage the CAPA process, including root cause analysis, action planning, execution, and effectiveness checks.
- Prepare and organize management review meetings in line with ISO 13485:2016 requirements.
- Provide active support during internal and external audits (e.g., MDSAP, certification bodies).
- Maintain and improve QMS processes (Document Control, Change Control, CAPA, Internal Audit).
- Ensure compliance with ISO 13485:2016 and MDSAP across multiple regulatory bodies (US FDA, Health Canada, TGA, ANVISA, PMDA).
Qualifications:
- Bachelor’s degree or equivalent in life sciences/technical discipline.
- ISO 13485:2016 Lead Auditor certification preferred.
- 2+ years’ experience in a regulated manufacturing industry.
- Knowledge of GMP, quality system standards, and biotech/medical device manufacturing processes.
- Experience with QMS databases (Veeva, SAP).
- Strong communication, time management, and organizational skills.
- Detail-oriented with multitasking ability.
Benefits:
- Comprehensive medical plans and insurance coverage.
- Flexible benefits and employee wellness programs.
- Extensive learning and development opportunities.
- Inclusive and collaborative work environment.
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