Blue Bridge People · 1 day ago
Quality Engineer Medical Device
Santa Clarita, CA
Contract
Hybrid
Mid, Senior Level
$55/hr - $70/hr
4+ years expBlue Bridge People is a medical device company seeking a Quality Engineer to provide contract support within Design Quality Assurance, focused on design verification for a program approaching regulatory submission. The role involves authoring design verification plans, executing testing, and collaborating with cross-functional teams to meet project timelines.
Artificial Intelligence (AI)ConsultingInformation Technology
Responsibilities
Author Design Verification Plans using approved internal templates
Execute Design Verification Testing against defined requirements
Prepare Design Verification Reports
Support verification planning activities such as:
Sample size determination
Coordination with technicians and cross-functional stakeholders
Document and communicate any issues identified during verification in alignment with QMS requirements
Collaborate with Design Assurance, R&D, and Program Management to meet aggressive timelines
Qualification
Required
Bachelor's degree in Engineering or a related technical field
4–10+ years of Quality Engineering experience within the medical device industry
Solid understanding of Medical device QMS
Solid understanding of Design verification / validation processes
Solid understanding of Requirements-based testing and documentation
Ability to independently draft plans, execute testing, and author reports
Proficiency in Microsoft Word, Excel, and PowerPoint
Strong communication and collaboration skills
Ability to work onsite in Valencia, CA at least three days per week
Preferred
Master's degree in Engineering or technical discipline
Experience supporting labeling, packaging, or design assurance activities
Background working on programs close to regulatory submission
Company
Blue Bridge People
Blue Bridge People offers talent solutions and workforce transformation services for the banking industry.
11-50 employees
Funding
Current Stage
Early StageLeadership Team
Frank Morris
CEO & Co-Founder
Sylvia Helm
CDO & Co-Founder
Company data provided by crunchbase