Jobs via Dice ยท 11 hours ago
Quality Engineer
Santa Clara, CA
Contract
Onsite
Mid Level
$45/hr - $45/hrDice is the leading career destination for tech experts at every stage of their careers. Their client, Generis TEK Inc., is seeking a Quality Engineer to provide compliance support to the Regulatory Affairs organization. The role involves managing audit preparedness, supporting quality system integration, and driving process improvement initiatives.
Computer Software
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
Experience in a Quality role
Experience in a Compliance role
Company
Jobs via Dice
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0-1 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase