Katalyst CRO · 3 hours ago
Senior Design Quality Engineer
Chicago, IL
Contract
Onsite
Senior Level, Lead/Staff
8+ years expKatalyst Healthcares & Life Sciences is looking for a Senior Design Quality Engineer to support quality assurance activities for electromechanical medical devices and combination products. This role involves working closely with R&D, Manufacturing, and Regulatory teams to ensure compliance with medical device quality and regulatory requirements throughout the product lifecycle.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
Responsibilities
Support quality activities across the product lifecycle for electromechanical and combination medical devices
Apply Design Controls (21 CFR 820.30 / ISO 13485) during product development
Review and approve design inputs/outputs, test protocols, and validation reports
Support design verification and validation testing for mechanical, electrical, and software-controlled systems
Participate in risk management activities (FMEA, hazard analysis, risk reviews)
Ensure traceability from user needs requirements verification validation
Support change control and engineering change assessments
Investigate quality issues and support root cause analysis and CAPA
Review DHF/DMR documentation for completeness and compliance
Partner with engineering and manufacturing teams to ensure quality is built into product design
Support supplier quality activities for critical components
Contribute to regulatory submission documentation as needed
Qualification
Required
Bachelor's and Master's degree in Mechanical, Electrical, Biomedical, or related Engineering field
8+ years Quality Engineering or Quality Assurance experience in medical devices
Hands-on experience with electromechanical medical devices
Strong working knowledge of Design Controls
Risk Management (ISO 14971)
ISO 13485 / FDA 21 CFR 820
Experience supporting verification & validation testing
Experience with DHF documentation and change control
Experience performing investigations and CAPA
Ability to work cross-functionally with engineering teams
Preferred
Experience with infusion pumps or drug delivery systems
Combination product experience
Knowledge of IEC 60601, IEC 62304, or IEC 62366
Experience supporting 510(k) or other regulatory submissions
ASQ CQE / CQA certification
Experience with eQMS systems
Company
Katalyst CRO
Katalyst CRO | Advancing Healthcare & Life Sciences with Expert Research & Regulatory Solutions Katalyst Healthcare & Life Sciences (Katalyst CRO) is a Global Contract Research and Knowledge Process Outsourcing Organization (CRO) dedicated to driving innovation in research, regulatory compliance, and quality excellence for pharmaceutical, biotechnology, and medical device companies worldwide.
51-200 employees
H1B Sponsorship
Katalyst CRO 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 (37)
2024 (14)
2023 (24)
2022 (52)
2021 (54)
2020 (39)
Funding
Current Stage
Growth StageLeadership Team
John Patil
Recruiter, Pharma/CRO Staffing Division
Recent News
2024-04-07
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