Title: Jr. Quality Associate (Medical Device/GMP/ISO regulations) (Hybrid)

Location: Hercules, CA (Hybrid - 2-3 days onsite) - Local candidates only

Payrate: $40/hour + weekly pay + benefits

Duration: 6-month contract with excellent potential for permanent conversion and extension

Hours: Full-time | Monday–Friday, Hybrid (3 days onsite per week)

Start Date: ASAP

Summary:

Are you the detail-oriented quality professional who ensures medical devices meet the highest safety standards before reaching patients worldwide? Join a global team of innovators as their Quality Associate, where you'll play a crucial role in updating and consolidating legacy product risk management files for IVDR compliance. This hybrid role in Hercules offers excellent work-life balance with only 2-3 days onsite while contributing to life-saving medical device innovations.

You'll be the quality champion facilitating critical risk management assessments that directly impact patient safety, working with cutting-edge life science instruments and reagents used in research laboratories and healthcare facilities globally. If you're passionate about quality excellence and want to make a meaningful impact in medical device safety while enjoying flexible hybrid work arrangements, this opportunity combines technical expertise with life-changing healthcare innovation.

What You'll Do:

• Facilitate comprehensive risk management assessments and update critical risk plans and reports for medical device compliance
• Lead consolidation and updating of product system hazard analysis files following established company procedures and applicable standards
• Coordinate strategic meetings with cross-functional stakeholders to gather essential information for accurate risk profiles
• Identify and assess existing hazards while proactively discovering new risks that could impact patient safety
• Escalate critical events to management requiring additional inputs or mitigation strategies
• Support seamless product risk management file migration into the eQMS system with precision and accuracy
• Ensure document metadata accuracy and proper linking to legacy product DHF binders during migration efforts
• Assess legacy risk documentation and identify gaps against IVDR transitional activities and updated guidance documents
• Support comprehensive IVDR-related technical documentation updates and gap assessments as required
• Navigate dynamic, ever-shifting environments while maintaining patience and professionalism with cross-functional teams
• Work independently as a self-starter with strong ownership and accountability for assigned quality activities

What You Bring:

• Bachelor's degree in a related technical or scientific discipline with strong analytical foundation
• 2-4 years of hands-on experience in Quality or quality-related education and training
• Solid understanding of Medical Device regulations within GMP (Good Manufacturing Practices)
• Strong knowledge of quality engineering principles, theories, and practical applications
• Understanding of ISO regulations including ISO 14971, ISO 13485, MDSAP, and FDA CFR Part 820
• Foundational knowledge of risk management regulations, principles, and real-world application
• Proficiency in Microsoft Office Suite, Livelink, and Visio for documentation and process mapping
• Exceptional attention to detail with ability to work independently and manage multiple priorities
• Strong communication skills for effective collaboration with cross-functional teams
• High level of patience and adaptability to support teams with shifting priorities

Bonus Points If You Have:

• SAP experience for enterprise resource planning integration
• EtQ and/or Veeva experience with quality management systems
• Experience with eQMS system implementation and migration projects
• Knowledge of IVDR (In Vitro Diagnostic Regulation) requirements and compliance
• Background in medical device manufacturing or life sciences industry
• Experience with Design History File (DHF) management and documentation
• Certification in quality management or risk management disciplines

This essential role puts you at the center of medical device safety, where your quality expertise directly protects patients and ensures life-saving technologies meet the highest standards. Enjoy hybrid flexibility in Hercules with excellent compensation, weekly pay, and comprehensive benefits while building your career with a global healthcare leader. Ready to combine your quality expertise with meaningful impact in medical device safety? Apply now and help ensure breakthrough healthcare solutions reach patients safely.

TCWGlobal is an equal opportunity employer. We do not discriminate based on age, ethnicity, gender, nationality, religious belief, or sexual orientation.