Collabera · 12 hours ago
Quality Engineering Manager – Medical Devices
North Chicago, IL
Contract
Onsite
Mid, Senior Level
$85/hr - $95/hrCollabera is seeking a Quality Engineering Manager for their Medical Devices division. This role is responsible for leading design quality and lifecycle management activities for medical device portfolios, ensuring compliance with regulatory and quality system requirements throughout the product lifecycle.
ConsultingInformation TechnologyInformation Services
Hiring Manager
Gagandeep Singh
Responsibilities
Serve as the primary quality lead for design transfer activities supporting product launches and manufacturing transitions
Drive quality and compliance aspects of product transfer and on-market change management initiatives
Lead and support lifecycle design change projects in alignment with design control and change control principles
Develop and manage change plans, conduct impact assessments, execute action plans, and ensure timely closure
Ensure design control documentation, traceability, and design change control requirements are met
Identify gaps within design history files and risk management documentation and track actions to closure
Support process validation activities including installation qualification, operational qualification, and performance qualification
Mentor and guide cross-functional teams through design transfer and lifecycle management processes
Collaborate with suppliers and contract manufacturers during change management activities
Support regulatory inspections and internal audits and represent quality as a subject matter expert
Lead or participate in investigations related to change plans, corrective and preventive actions, and nonconformances
Propose and implement process and quality system improvements and support procedure development
Qualification
Required
Bachelor's degree in engineering, science, or a related technical discipline
Extensive experience in design quality or quality assurance within medical devices or combination products
Strong working knowledge of design control and change control principles
Experience supporting product lifecycle management and design transfer activities
Working knowledge of global medical device and combination product regulations and standards
Ability to lead cross-functional teams and influence stakeholders in a matrix environment
Strong problem-solving, communication, and project management skills
Ability to work effectively in a fast-paced and regulated environment
Preferred
Advanced technical or scientific degree
Professional quality certification
Experience with infusion pumps, prefilled syringes, autoinjectors, or on-body injector products
Experience supporting regulatory inspections and audits
Experience working with external suppliers or contract manufacturers
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.
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
2026-02-06
2024-04-09
2023-01-20
Company data provided by crunchbase