Quality Engineer III

Quality Engineer III – Santa Clara, California (100% Onsite). 12‑Month contract. Pay $50 – $55 per hour (W2). Job Summary This role provides compliance support to the Regulatory Affairs organization, with opportunities to investigate nonconformances (CAPAs) and implement mitigations. Exposure to Medical Device US and CE regulations, quality systems, or compliance roles is a plus. Top Skills Change management (change orders for procedural updates) Develop and implement an auditing plan for critical RA tasks (e.g., mock audits for Technical Files/Documentation, Impact Assessments, Archival) as part of audit risk mitigation activities. CAPAs/Audit finding management. Post-Approval Commitments management. Support QMS audits from an RA perspective & support QMS integration tasks. Management review metrics results. Job Responsibilities Driving preparation of KPI dashboards and maintaining a pulse on formal RA management review and internal metrics. Managing strategic programs for RA audit preparedness, including anticipatory identification of risks, mitigation of risks identified during the audit process, and preventative actions for risks. Supporting quality system integration for acquisitions and new product introductions. Identifying and implementing system and/or systemic processes. Supporting tracking and maintenance of regulatory post-approval commitments. Driving quality system process improvement initiatives. 5-7 years of experience. Initiatives include but are not limited to: establishing audit support for integration products, improving and maintaining the quality system procedures (e.g., change management), liaising with cross-functional partners and international affiliates to meet compliance needs and drive implementation/resolution, participating in audit backrooms, and participating in RA projects. Skills Independent Troubleshooting Critical thinker Ability to drive a problem through resolution and implement mitigations. Ability to handle multiple streams simultaneously. #J-18808-Ljbffr ManpowerGroup Global, Inc.