Primary Role:
The Quality System Specialist (Fixed Term) supports the Quality Management System (QMS) implementation and maintenance in alignment with ISO 9001:2015, SS620:2016, ISO 13485, and GDPMDS requirements. This role is pivotal in ensuring regulatory compliance, audit readiness, and continuous improvement within the Singapore Distribution Centre (SG DC). A significant portion (50%) of the role is dedicated to In Vitro Diagnostic Regulation (IVDR)-related activities, especially in labelling, traceability, document control, and audit support.
How You’ll Make an Impact:
- Quality Assurance Related Activities
- Maintain and improve the QMS to meet applicable regulatory standards and business objectives.
- Support internal audits by preparing relevant documentation and ensuring process adherence.
- Identify nonconformances (NCs), perform root cause analysis, issue Corrective Action Reports, and conduct effectiveness checks.
- Oversee Quality Notifications (QNs), including plant-to-plant issues, Global Ship Hold, posting changes, and scrap orders via SAP.
- Execute final quality checks for both IVDR and non-IVDR product shipments to ensure correct labelling and compliance.
- Inspect returned/nonconforming products, provide disposition decisions, and ensure accurate system status updates.
- Ensure cold chain integrity, place and assess data loggers in shipments, and escalate any temperature deviations.
- Respond to customer queries and provide regulatory clarification on label content, placement, and symbol usage.
- Regulatory Related Activities
- Coordinate labelling verification and approvals for IVDR and non-IVDR products with Regulatory Affairs (RA), suppliers, and internal stakeholders.
- Perform traceability and batch verification checks, ensuring alignment with ERP system data and physical packaging.
- Support documentation and report preparation for import/export licenses and other regulatory compliance efforts.
- Regulatory Surveillance and Document Control
- Maintain regulatory standards libraries and keep external guidance documents up to date.
- Review and update SOPs and documentation for compliance with IVDR, ISO 13485, GDPMDS, and ISO 9001 standards.
- Assist in communication and dissemination of controlled documents (SOPs, WIs, Forms) across distribution and sales functions.
- Audit Support
- Participate in internal and external audits, prepare supporting documents, and provide walkthroughs for processes related to IVDR and non-IVDR activities.
- Ensure all audit findings are followed up with timely CAPA and closure tracking.
- Customer and Stakeholder Support
- Address QA-related inquiries, including those related to product labelling, regulatory symbol usage, and documentation.
- Provide support and clarity on compliance issues raised by internal teams or customers.
What you bring
- Diploma or Bachelor’s degree or equivalent in Biology, Chemistry, Medical Technology, or related field
- 1-2 years related experience or equivalent combination of education and experience
- Basic analytical, communication, problem solving, critical thinking, and computer skills
- Working knowledge of policies, practices and procedures relating to Quality Assurance
- Uses tact and cooperative relationships
Who We Are: For 70 years, Bio-Rad has focused on advancing the discovery process and transforming the fields of science and healthcare. As one of the top five life science companies, we are a global leader in developing, manufacturing, and marketing a broad range of high-quality research and clinical diagnostic products. We help people everywhere live longer, healthier lives. Recently voted a Best Place to Work, Bio-Rad offers a unique employee experience with collaborative teams that span the globe. Here, you are supported by leadership to build your career and are empowered to drive change that makes an impact you can see.
Benefits: Bio-Rad's biggest asset is our people, and this is the reason why our Total Rewards deliver programs that provide value, quality, and inclusivity while satisfying the diverse needs of our evolving workforce. Our offerings serve to enrich the overall health, wealth, and wellbeing of our employees and their families through the various stages of an employee’s work and life cycle. We’re proud to offer comprehensive medical plans and insurance, wellness programs, extensive learning and development opportunities and more.
EEO Statement: Bio-Rad is an Equal Employment Opportunity/Affirmative Action employer, and we welcome candidates of all backgrounds. Veterans, people with disabilities, and people of all races, ethnicities, genders, ages, and orientations are encouraged to apply.
Agency Non-Solicitation: Bio-Rad does not accept agency resumes, unless the agency has been authorized by a Bio-Rad Recruiting Representative. Please do not submit resumes unless authorized to do so. Bio-Rad will not pay for any fees related to unsolicited resumes.
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