SPECTRAFORCE · 1 week ago
Quality Engineer
Santa Clara, CA
Contract
Onsite
Mid LevelSPECTRAFOR is seeking a Quality Engineer to provide compliance support to the Regulatory Affairs organization. The role involves driving the preparation of KPI dashboards, managing audit preparedness, and supporting quality system integration for acquisitions and new product introductions.
ConsultingCRMInformation TechnologyLegal
Hiring Manager
Naina Rathi
Responsibilities
Driving preparation of KPI dashboards and maintaining a pulse on formal RA management review and internal metrics
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
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
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 driving to implementation/resolution
Participating in audit backrooms
Participating in RA projects
Change management (change orders for procedural updates)
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
Qualification
Required
Driving preparation of KPI dashboards and maintaining a pulse on formal RA management review and internal metrics
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
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
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 driving to implementation/resolution
Participating in audit backrooms
Participating in RA projects
Change management (change orders for procedural updates)
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/Auditing Finding management
Post-Approval Commitments management
Support QMS audits from an RA perspective
Support QMS Integration tasks
Management Review Metrics results
Independent
Troubleshooting
Critical thinker
Ability to drive a problem through resolution and implement mitigations
Ability to handle multiple streams simultaneously
Preferred
Exposure to Medical Device US and CE regulations
Quality Systems experience
Quality role experience
Compliance role experience
Company
SPECTRAFORCE
Welcome to SPECTRAFORCE, your gateway to NEWJOBPHORIA™! Established in 2004, SPECTRAFORCE is now one of the largest and fastest growing U.S.
Founded in 2004
1001-5000 employees
H1B Sponsorship
SPECTRAFORCE has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (3)
2024 (6)
2023 (1)
2022 (6)
2021 (8)
2020 (7)
Funding
Current Stage
Late StageCompany data provided by crunchbase