Katalyst CRO · 16 hours ago
Quality Engineer
Broadview Heights, OH
Contract
Onsite
Senior Level, Lead/Staff
24+ years expKatalyst CRO is a company focused on supporting design control and quality activities for regulated medical device products. The Quality Engineer will be responsible for executing design verification and validation, managing risk and change processes, and maintaining technical documentation in compliance with ISO and FDA regulations.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
Responsibilities
Lead DHF/DMR/DMR build activities in adherence to ISO 13485 and FDA 21 CFR Part 820 design control requirements
Execute Design Verification and Validation (DVV) protocols, including test planning, execution, and reporting
Manage change management processes in compliance with ISO 14971 risk management and internal quality procedures
Coordinate project activities across Quality, Regulatory, Manufacturing, and Supply Chain teams
Create and maintain technical documentation including Design History File (DHF), risk assessments, and engineering reports
Support design reviews and ensure traceability of requirements throughout the product lifecycle
Qualification
Required
Bachelor's degree in Engineering or a related life sciences/technical field
24+ years of experience in a Quality Engineer role within the life sciences or medical device industry
Proficiency in CAD tools (SolidWorks, PTC Creo), GD&T, tolerance analysis, and fixture design
Experience with statistical analysis (95/95, tolerance intervals), Minitab, and data integrity practices
Familiarity with materials and processes including titanium alloys, CoCr, stainless steel, UHMWPE, PEEK, additive manufacturing, and coatings
Knowledge of ISO 13485, ISO 14971, FDA regulatory pathways (510(k), PMA, MDR), DFMEA/pFMEA, and requirements traceability
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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