Quality Engineer IV (Contingent Worker Regulatory ...
ATR International - santa clara, CA
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We are seeking a Quality Engineer IV/ Contingent Worker Regulatory Operations for a very important client This role will provide compliance support to the Regulatory Affairs organization by - a Driving preparation of KPI dashboards and maintaining a pulse on formal RA management review and internal metrics. b Managing strategic program for RA audit preparedness including anticipatory identification of risks, mitigation of risks identified during the audit process, and preventive actions for risks. c Supporting quality system integration for acquisitions and new product introductions. d Identifying and implementing system and/or systemic processes. e Supporting tracking and maintenance of regulatory post-approval commitments. f Driving quality system process improvement initiatives Initiatives include but are not limited to: 1 Establishing audit support for integration products, 2 Improving and Maintaining the quality system procedures (e.g., change management) 3 Liaising with cross-functional partners and international affiliates to meet audit compliance needs and driving to implementation/resolution. 4 Participating in audit backrooms, and 5 Participating in RA projects List of tasks: • RA Change Requests Tracking and Closure • Change management • Develop and implement an "auditing plan" for critical RA tasks (e.g., mock audits for Technical Files/Technical Documentations, Impact Assessments, Archival) as part of audit risk mitigation activities. • CAPAs/Auding Finding management. • Post-Approval Commitments management • Support QMS audits from an RA perspective • Support QMS Integration tasks • Management Review Metrics results Requirement: The ideal candidate will possess the following qualifications: Role has a potential for investigating nonconformances (CAPAs) and implementing mitigations Exposure to Medical Device US and CE regulations, Quality Systems, a Quality role, or a Compliance role is a plus. Skills: • Independent • Troubleshooting • Critical thinker • Ability to drive a problem through resolution and implement mitigations. • Ability to handle multiple streams simultaneously. Benefits: Benefits include: -MEC/ACP Medical -Voluntary Dental, Vision, Life, Supplemental Income -401k (must meet requirements) -sick leave as required by state/county
Created: 2024-10-08