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:
• Medical and Prescription Drug Plans
• Dental Plan
• Supplemental Life Insurance
• Short Term Disability Insurance
• 401(k)