Collabera · 6 hours ago
Senior Quality Engineer- Medical Device
Collabera is seeking a Senior Quality Engineer to support quality assurance activities within a regulated medical device environment. The role involves overseeing quality activities across software development, manufacturing, operations, and engineering functions to ensure compliance with regulatory standards.
Responsibilities
Support quality activities for software development, manufacturing, operations, and engineering teams
Review and approve software development lifecycle documentation for compliance
Lead and support hazard analysis and risk management activities
Assist with the development and maintenance of standard operating procedures and work instructions
Support occasional training activities related to quality processes
Write and execute test protocols and prepare test reports as needed
Qualification
Required
Bachelor's degree in Engineering, Life Sciences, or a related technical field
Medical device quality experience within manufacturing or operations environments
Strong working knowledge of applicable regulatory and quality standards, including ISO standards and risk management requirements
Ability to ramp up quickly and work independently in a regulated environment
Professional experience in quality engineering or a related quality role
Preferred
Experience supporting software-related quality activities
Prior involvement with hazard analysis and risk management documentation
Experience working in a fast-paced medical device manufacturing environment
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 off
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.
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
Recent News
2024-04-09
2023-01-20
2022-04-19
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