Katalyst CRO · 3 months ago
Quality Control Engineer
Irvine, CA
Full-time
Onsite
Entry, Mid Level
2+ years expKatalyst CRO is seeking a highly motivated and detail-oriented Quality Control Engineer to join their team in Irvine, California. The ideal candidate will support Quality Assurance, Supplier Quality Engineering, and Quality Control functions, ensuring compliance with ISO 13485 and FDA regulations while maintaining product integrity and driving continuous improvement in manufacturing processes.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
Responsibilities
Develop, implement, and maintain a compliant Quality Management System (QMS) per ISO 13485 and FDA 21 CFR Part 820
Lead internal and external audits; manage CAPA processes and follow-up activities
Conduct risk assessments (e.g., PFMEA) and ensure integration of quality into product development and manufacturing
Create, revise, and control SOPs, work instructions, forms, and quality records
Support equipment and process validations (IQ, OQ, PQ) for tubing manufacturing processes
Participate in customer audits and regulatory inspections
Collaborate with cross-functional teams (Engineering, Production, R&D) to define CTQ (Critical-to-Quality) parameters and ensure product quality
Maintain and organize Device History Records (DHRs), Device Master Records (DMRs), and training logs
Qualify and onboard new suppliers; conduct supplier audits and evaluations
Define incoming inspection requirements to ensure component conformance
Manage supplier non-conformances and issue Supplier Corrective Action Requests (SCARs)
Partner with suppliers to drive process improvements and implement corrective actions
Perform incoming, in-process, and final inspections of extruded, shrink, and braided tubing
Conduct First Article Inspections (FAIs) and maintain accurate inspection records
Develop and execute test methods and protocols for product performance and reliability
Track and analyze production quality metrics (scrap rate, yield, defect rate)
Calibrate and maintain inspection tools and metrology equipment
Utilize precision tools such as micrometers, laser micrometers, pin gauges, tensile testers, etc
Ensure visual and dimensional quality meets specifications and customer requirements
Initiate and manage Non-Conformance Reports (NCRs) and assist in root cause analysis
Maintain calibration logs to ensure all inspection instruments are current and accurate
Qualification
Required
Bachelor's degree in Materials Engineering, Quality, Mechanical, or a related technical field
Solid understanding of ISO 13485 and FDA QSR (21 CFR Part 820) requirements
Proficiency with quality tools such as CAPA, FMEA, 5 Whys, and Fishbone Diagrams
Strong attention to detail, documentation, and organizational skills
Hands-on experience with inspection techniques and measurement equipment
Ability to excel in a fast-paced, startup environment
Excellent communication, analytical, and problem-solving skills
Preferred
2+ years of experience in QA/SQE/QC roles within the medical device industry (preferred)
Familiarity with catheter manufacturing processes (extrusion, shrink tubing, or braiding) strongly preferred
Experience in catheter manufacturing processes
ASQ certification (CQE, CQA, or equivalent)
Mandarin language proficiency is a plus
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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