Quality System Specialist I - Temporary

The Quality System Specialist will assist in the updating and consolidation of legacy product design, development and technical files related to IVDR. Responsibilities include:

• Identifying and digitizing physical records to transfer into the Bio-Rad eQMS and regulatory databases.
• Coordinating and facilitating meetings with cross-functional stakeholders as necessary to gather information and data required for the completeness and accuracy of migrated documentation.
• Supporting the migration of product design and technical records into the eQMS system, ensuring document metadata is accurate and files are correctly linked to legacy product DHF and IVDR Technical File binders in coordination with DHF migration efforts.
• Assessing legacy design and technical documentation and identifying gaps relative to initial IVDR transitional activities versus new guidance documents and updates, as needed, to global quality management procedure requirements.
• Supporting other IVDR-related technical documentation updates and gap assessments as required, including identification of legacy design and development documentation and migration into eQMS as necessary (document scanning, archiving, etc.).

The candidate must possess the ability to work in a dynamic environment and demonstrate a high level of patience to support cross-functional teams with shifting priorities. The individual should be self-motivated, able to work independently, and have a sense of ownership and accountability for the tasks assigned.

How You'll Make An Impact:

• Coordinating meetings with cross-functional stakeholders to gather essential information and data to ensure the completeness and accuracy of product design and development and technical file documentation.
• Supporting the migration of files into the eQMS system by verifying document metadata accuracy and ensuring correct linkage to legacy product DHF and IVDR Technical File binders, in alignment with DHF migration initiatives.
• Assisting with additional IVDR-related technical documentation updates and gap assessments-including eQMS migration-when necessary.
• Operating effectively within a dynamic environment and supporting cross-functional teams amid shifting priorities.
• Demonstrating initiative, working autonomously, and maintaining accountability and ownership of assigned responsibilities.

What You Bring:

• High school diploma or equivalent. Some college a plus.
• 1 +years experience in a regulated manufacturing industry or equivalent combination of education and experience.
• Detail-oriented and ability to multitask.
• Basic understanding of GMP and quality system standards desirable.
• Proficient in Microsoft Office, Visio, Copilot. Experience with eQMS systems (EtQ, Veeva a plus).

Compensation: The estimated hourly range for this position is $32 to $35 per hour at the time of posting. Actual compensation will be provided in writing at the time of offer, if applicable, and is based on several factors we believe fairly and accurately impact compensation, including geographic location, experience, knowledge, skills, abilities, and other job permitted factors. As a temporary associate, your employment will be managed directly through our approved agency provider.

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. 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.

EEO Statement: Bio-Rad is an Equal Employment Opportunity/Affirmative Action employer, and we welcome candidates of all backgrounds. Veterans, people with physical or mental disabilities, and people of all race, color, sex, sexual orientation, gender identity, religion, national origin and citizenship status 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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