Quality Systems Specialist I (Biotech/ Migration of Design History Files into eQMS)

Hybrid position for a top Biotech/Med Device company in Hercules, CA. Monday

• Friday, (8am
• 5pm), Hybrid, 3 days on site TBD
• Quality System Specialist I
• will assist in the updating and consolidation of legacy product design, development and technical files related to IVDR.
• Experience with eQMS systems (EtQ, Veeva a plus).
• 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.

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 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.

What You Bring:

Education:

High school diploma or equivalent. Some college a plus.

Work Experience:

1

• 3 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).

Job Disclaimer:

Equal Opportunity Employer/Veterans/Disabled Benefit offerings include medical, dental, vision, term life insurance, short-term disability insurance, additional voluntary benefits, commuter benefits and 401K plan. Our program provides employees the flexibility to choose the type of coverage that meets their individual needs. Available paid leave may include Paid Sick Leave, where required by law; any other paid leave required by Federal, State or local law; and Holiday pay upon meeting eligibility criteria.

Disclaimer:

These benefit offerings do not apply to client-recruited jobs and jobs which are direct hire to a client To read our Candidate Privacy Information Statement, which explains how we will use your information, please visit https://www.entegee.com/candidate-privacy-information-statement/ The Company will consider qualified applicants with arrest and conviction records. #

GRPA Pay:

$35.00

• $40.

00 per hour People with a criminal record are encouraged to apply

Work Location:

Hybrid remote in Hercules, CA 94547