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Network / Systems Administrator
Hercules, CA
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If you're detail-oriented, thrive in regulated environments, and enjoy collaborating across teams to improve quality systems and compliance, this could be an exciting opportunity. Join a leading life sciences organization and play a key role in supporting IVDR compliance initiatives, risk management activities, and technical documentation updates that directly impact product quality and patient safety.
Location:
Hercules, CA (Hybrid)
Pay Rate:
$40.00/hour
Employment Type:
Contingent, 6-
Month Contract Schedule:
Day Shift Why This Role Matters The Quality System Specialist will support critical IVDR-related initiatives by updating and consolidating legacy product design, technical documentation, and risk management files. This role plays an important part in maintaining regulatory compliance, improving documentation accuracy, and supporting successful migration of quality records into eQMS systems. What You'll Do
Facilitate product risk management assessments and update risk plans, reports, and hazard analysis files in accordance with company procedures and applicable standards
Coordinate meetings with cross-functional teams to gather information needed to maintain complete and accurate risk profiles
Identify new hazards and risks while escalating issues that require additional management review or mitigation
Support migration of risk management files and technical documentation into the eQMS system, ensuring accurate metadata and document linkage
Assess legacy design, technical, and risk documentation for gaps related to IVDR requirements, guidance updates, and quality procedures
Assist with technical documentation updates, document scanning, and migration activities as needed
Work effectively in a fast-paced environment while supporting multiple priorities and stakeholders
Demonstrate ownership, accountability, and initiative when managing assigned activities What We're Looking For
A current, up-to-date resume
Associate degree in Biology, Chemistry, Engineering, or a related field
2+ years of experience in regulated manufacturing or equivalent education and experience
Knowledge of GMP and ISO regulations, including ISO 13485, MDSAP, and
FDA 820/210/211
requirements
Familiarity with medical device, pharmaceutical, or biotechnology manufacturing processes
Strong organizational, project management, and multitasking abilities
Effective decision-making, communication, time management, and computer skills
Proficiency with Microsoft Office Suite, Excel, and Visio
Experience with Salesforce, Veeva, EtQ, and/or SAP is preferred
Experience in product design, development, and risk management is a plus
Ability to work independently while collaborating effectively across functional teams
Ability to meet compliance requirements What's In It For You
Competitive hourly pay
Hybrid work environment offering flexibility and collaboration
Opportunity to support high-visibility IVDR and quality system initiatives
Hands-on experience with eQMS and regulated quality documentation processes
Exposure to cross-functional teams across quality, regulatory, and product development functions
Build valuable experience within a global life sciences and diagnostics environment
Develop expertise in risk management and regulatory compliance activities Benefits for Manpower Associates (Upon Eligibility) Upon completion of waiting period associates are eligible for: