Collabera · 20 hours ago
Quality Engineer (Medical Devices)
Santa Clara, CA
Contract
Onsite
Mid Level
$42/hr - $43/hrCollabera is a Medical Devices Manufacturer, and they are seeking a Quality Engineer to provide compliance and quality system support to the Regulatory Affairs organization. The role involves ensuring audit readiness, regulatory compliance, and continuous improvement of quality processes.
ConsultingInformation ServicesInformation Technology
Hiring Manager
Mradul Khampariya
Responsibilities
Develop and maintain KPI dashboards and regulatory metrics to support RA management reviews
Lead audit preparedness initiatives, including risk identification, mitigation, and preventive actions
Support Quality Management System (QMS) integration for acquisitions and new product introductions
Drive quality system and process improvement initiatives, including change management activities
Track and maintain regulatory post-approval commitments
Establish and support audit readiness for integrated products, including mock audits
Partner with cross-functional teams and international affiliates to meet regulatory compliance requirements
Participate in audit backrooms and support Regulatory Affairs projects
Manage change orders and procedural updates
Develop and execute audit plans for critical RA activities (e.g., Technical Files, Technical Documentation, Impact Assessments, Archival)
Manage CAPAs and audit findings, including investigation and mitigation
Support QMS audits from a Regulatory Affairs perspective
Assist with QMS integration activities
Prepare and report management review metrics
Qualification
Required
Strong understanding of Quality Systems and regulatory compliance
Experience supporting audits, CAPAs, and change management
Ability to work independently and manage multiple priorities
Strong troubleshooting, critical thinking, and problem-solving skills
Proven ability to drive issues through resolution and implement effective mitigations
Preferred
Exposure to U.S. FDA and CE medical device regulations
Benefits
Medical insurance
Dental insurance
Vision insurance
401(k) retirement plan
Life insurance
Long-term disability insurance
Short-term disability insurance
Paid parking/public transportation
Paid time
Paid sick and safe time
Hours of paid vacation time
Weeks of paid parental leave
Paid holidays annually - AS Applicable
Company
Collabera
Collabera is an end-to-end information technology services and solutions provider helping clients align their business and IT strategies.
Founded in 1991
10001+ employees
H1B Sponsorship
Collabera 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 (141)
2024 (93)
2023 (120)
2022 (186)
2021 (180)
2020 (146)
Funding
Current Stage
Late StageTotal Funding
$30M2006-05-04Series Unknown· $30M
Leadership Team
Lalit Sharma
CFO
Michael H. Abraham
Chief Financial Officer
Recent News
2024-04-09
2023-01-20
2022-04-19
Company data provided by crunchbase