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 companyโs 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-Radโs 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:
- Bachelorโs degree or equivalent in life sciences/technical discipline.
- ISO 13485:2016 Lead Auditor certification preferred.
- 2+ yearsโ 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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