Quality Sys Spec II
- Singapore
- Permanent
- Full-time
- Manage the change request process, ensure timely review and arrange change control meetings to review changes related to design, manufacturing processes, product design and documentation. Collaborate with internal stakeholders (e.g., Manufacturing Engineering, Quality Control, Value Engineering) and external stakeholders (e.g., R&D, Regulatory Affairs) to assess change impact and ensure alignment.
- Support and co-manage the Corrective and Preventive Action (CAPA) process with CAPA owners, ensuring root cause analysis, action plan development & execution and effectiveness checks, and timely closure.
- Prepare and organize materials for periodic management review meetings in accordance with ISO 13485:2016. Coordinate meeting logistics, scheduling, and follow-up actions to ensure effective review and decision-making.
- Provide active support during internal audits and external audits/inspections (e.g., Certification Body, MDSAP), including front room and war room roles. Ensure audit readiness by maintaining up-to-date documentation and records.
- Support the maintenance and improvement of QMS processes including Document Control, Change Control, CAPA, Internal Audit, and Management Review. Ensure alignment with ISO 13485:2016 and MDSAP regulatory frameworks across participating countries (e.g., US FDA, Health Canada, TGA Australia, ANVISA Brazil, PMDA Japan).
- Bachelor’s degree or equivalent in a related life science/technical discipline or equivalent preferred.
- ISO 13485:2016 Lead Auditor certified preferred
- At least 2+ years experiences in a regulated manufacturing industry or equivalent combination of education and experience.
- Experience with QMS Databases (i.e., Veeva, SAP).
- Understanding of GMP and quality system standards as they apply to products manufactured by Bio-Rad.
- Strong communication and coordination skills across cross-functional and global teams.
- Decision making, time management, organization and computer skills.
- Working knowledge of In-Vitro Diagnostic Device/Medical Device/Biotech manufacturing processes.
- Detail-oriented and ability to multitask.