Katalyst CRO · 1 day ago
Quality Engineer
Miami, FL
Contract
Onsite
Senior Level
5+ years expKatalyst CRO is seeking an experienced Quality Engineer who will be a key on-site point of contact for quality issue management. The Quality Engineer will be responsible for managing quality issues, collaborating with suppliers, and leading continuous improvement initiatives to ensure adherence to quality metrics and standards.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
Responsibilities
Serve as the primary on-site point of contact for incoming quality issues
Qualify, triage, and dispatch quality issues to appropriate teams
Conduct systematic root cause analysis using methodologies such as 5-Why, fishbone diagrams, 8D, or FMEA to determine underlying causes of quality issues
Document quality issues in appropriate tracking systems
Reach out to suppliers to address and resolve quality issues
Collaborate with suppliers to develop and implement corrective action plans
Verify effectiveness of supplier corrective actions
Analyze quality documentation to ensure compliance with standards and specifications
Identify patterns or trends in quality issues and propose relevant solutions
Develop, maintain, and update technical documentation including SOPs, Work Instructions, and Job Aids by working directly with subject matter experts to accurately capture complex processes
Ensure documentation is clear, standardized, version-controlled, and compliant with internal quality systems and applicable regulatory requirements
Ensure the right quality metrics are met and maintained
Prepare and deliver regular quality performance reports to stakeholders
Share outcomes of quality analyses at defined frequencies during review meetings
Communicate effectively with internal teams and external partners regarding quality concerns
Actively participate in improving day-to-day quality activities, reporting mechanisms, and methods
Contribute to the development and refinement of Key Performance Indicators (KPIs)
Qualification
Required
Bachelor's degree in engineering, Quality Assurance, or related technical field
5-10 years of experience in quality engineering, supplier quality management, or related roles
Knowledge of quality management systems and standards
Proficiency in root cause analysis methodologies and problem-solving techniques
Experience in drafting quality processes & work instructions
Strong analytical and documentation skills
Excellent communication and interpersonal abilities
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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