Collabera · 14 hours ago
Entry Level Manufacturing Line Quality Engineer- Medical Device
Collabera is seeking a Quality Engineer II to support manufacturing and process quality activities in the medical device sector. This role focuses on ensuring products meet quality standards and regulatory requirements while driving process control and continuous improvement initiatives.
Responsibilities
Identify and implement effective process control systems to support product development, qualification, and ongoing manufacturing
Lead the implementation of process controls and corrective and preventive action systems to meet internal and external requirements
Apply structured problem-solving methodologies to investigate, prioritize, and resolve quality issues
Design, execute, and document experiments to support process optimization and improvement initiatives
Lead process monitoring and control of critical to quality parameters and specifications
Drive product and process improvement initiatives using methodologies such as Lean Manufacturing and Six Sigma
Lead investigations and prevention activities related to product and process nonconformances
Participate in cross functional teams and represent quality as a core team member
Complete and maintain risk analysis documentation in collaboration with stakeholders
Support product verification and validation activities with design engineering teams
Collaborate with microbiology teams to ensure environmental monitoring requirements are met
Ensure compliance with quality management systems and applicable regulatory requirements
Qualification
Required
Bachelor's degree in Engineering or a related technical discipline
Three to five years of experience in a manufacturing or quality engineering role
Hands on experience with root cause analysis and corrective and preventive action processes
Working knowledge of process control systems and quality improvement tools
Strong documentation, communication, and cross functional collaboration skills
Preferred
Experience in regulated manufacturing environments
Knowledge of Lean Manufacturing or Six Sigma methodologies
Experience supporting direct manufacturing floor operations
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
Company data provided by crunchbase