Katalyst CRO
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Continue with Google Continue with Google Continue with Google Continue with Google Continue with Google Continue with Google Continue with Google Continue with Google Continue with Google Continue with Google Continue with Google Continue with Google Develop and execute validation protocols (IQ/OQ/PQ), capability studies, and risk analyses (pFMEA). Support First Article Inspections, customer requirements, and regulatory compliance. Manage nonconformance investigations, CAPA, and supplier corrective actions. Develop and maintain quality documentation, test methods, and process standards. Provide support to manufacturing teams during process changes and quality issues. Assist with audits, customer complaints, and training of staff on quality methods.
Responsibilities
Develop and execute validation protocols (IQ/OQ/PQ), capability studies, and risk analyses (pFMEA). Support First Article Inspections, customer requirements, and regulatory compliance. Manage nonconformance investigations, CAPA, and supplier corrective actions. Develop and maintain quality documentation, test methods, and process standards. Provide support to manufacturing teams during process changes and quality issues. Assist with audits, customer complaints, and training of staff on quality methods.
Requirements:
Bachelor's degree in engineering or related experience in Quality Assurance. Strong knowledge of ISO 13485, FDA QSR, and validation requirements (IQ/OQ/PQ). Experience with GD&T, metrology, statistical analysis, and quality tools. Excellent communication, problem-solving, and cross-functional collaboration skills. Seniority level
Seniority level Entry level Employment type
Employment type Full-time Job function
Job function Quality Assurance Industries Biotechnology Research and Civil Engineering Referrals increase your chances of interviewing at Katalyst CRO by 2x Sign in to set job alerts for “Quality Engineer” roles.
Continue with Google Continue with Google Continue with Google Continue with Google Madison, WI $85,000 - $120,000 3 weeks ago Lead Supplier Quality and Development Engineer
Supplier Quality Talent Community - General Interest Pipeline
Madison, WI $70,000.00 - $110,000.00 1 day ago Manufacturing/Process Engineer Intern- Summer 2026
Manufacturing Engineer Intern - Summer 2026
Sr. Manufacturing Engineer, Injection Molding/Plastics
Madison, WI $89,000 - $151,000 2 weeks ago Madison, WI $100,000 - $150,000 1 week ago Madison, WI $62,000 - $102,000 15 hours ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
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Quality Engineer
role at
Katalyst CRO Continue with Google Continue with Google Join to apply for the
Quality Engineer
role at
Katalyst CRO Continue with Google Continue with Google Continue with Google Continue with Google Get AI-powered advice on this job and more exclusive features. Sign in to access AI-powered advices
Continue with Google Continue with Google Continue with Google Continue with Google Continue with Google Continue with Google Continue with Google Continue with Google Continue with Google Continue with Google Continue with Google Continue with Google Develop and execute validation protocols (IQ/OQ/PQ), capability studies, and risk analyses (pFMEA). Support First Article Inspections, customer requirements, and regulatory compliance. Manage nonconformance investigations, CAPA, and supplier corrective actions. Develop and maintain quality documentation, test methods, and process standards. Provide support to manufacturing teams during process changes and quality issues. Assist with audits, customer complaints, and training of staff on quality methods.
Responsibilities
Develop and execute validation protocols (IQ/OQ/PQ), capability studies, and risk analyses (pFMEA). Support First Article Inspections, customer requirements, and regulatory compliance. Manage nonconformance investigations, CAPA, and supplier corrective actions. Develop and maintain quality documentation, test methods, and process standards. Provide support to manufacturing teams during process changes and quality issues. Assist with audits, customer complaints, and training of staff on quality methods.
Requirements:
Bachelor's degree in engineering or related experience in Quality Assurance. Strong knowledge of ISO 13485, FDA QSR, and validation requirements (IQ/OQ/PQ). Experience with GD&T, metrology, statistical analysis, and quality tools. Excellent communication, problem-solving, and cross-functional collaboration skills. Seniority level
Seniority level Entry level Employment type
Employment type Full-time Job function
Job function Quality Assurance Industries Biotechnology Research and Civil Engineering Referrals increase your chances of interviewing at Katalyst CRO by 2x Sign in to set job alerts for “Quality Engineer” roles.
Continue with Google Continue with Google Continue with Google Continue with Google Madison, WI $85,000 - $120,000 3 weeks ago Lead Supplier Quality and Development Engineer
Supplier Quality Talent Community - General Interest Pipeline
Madison, WI $70,000.00 - $110,000.00 1 day ago Manufacturing/Process Engineer Intern- Summer 2026
Manufacturing Engineer Intern - Summer 2026
Sr. Manufacturing Engineer, Injection Molding/Plastics
Madison, WI $89,000 - $151,000 2 weeks ago Madison, WI $100,000 - $150,000 1 week ago Madison, WI $62,000 - $102,000 15 hours ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr