Generis Tek Inc · 14 hours ago
Quality Engineer
Santa Clara County, CA
Contract
Onsite
Mid Level
$45/hr - $45/hrGeneris Tek Inc is seeking a Quality Engineer for a contract role in Santa Clara, CA. The role involves providing compliance support to the Regulatory Affairs organization, driving quality system process improvements, and managing audit preparedness initiatives.
Information Technology & Services
Hiring Manager
Megan Bell
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, and participating in RA projects
Investigating nonconformances (CAPAs) and implementing mitigations
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
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
A Quality role
A Compliance role
Company
Generis Tek Inc
Generís Tek is an elite IT staffing firm headquartered in Chicago, IL offering long-term, short-term, temporary-to-permanent and direct placement staffing.
Founded in 2015
51-200 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase