Katalyst CRO
Sr Quality Engineer
Katalyst CRO - Tempe, Arizona, us, 85285
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Overview
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Overview
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Sr Quality Engineer
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Katalyst CRO Join to apply for the
Sr Quality Engineer
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Katalyst CRO Get AI-powered advice on this job and more exclusive features. In this Sr Quality Systems Specialist for Operations Quality, you will have responsibility for the Quality and Compliance of process development. Manufacturing of implantable electronic products at our client Tempe Campus. Responsibilities may include the following and other duties may be assigned. Ensure internal quality processes, procedures and systems are compliant to all governing standards. Support manufacturing development and continuous improvement as the Quality team member for process development and validation including. Equipment Development, IQ, Process Characterization, OQPQ and Test Method Development and Validation. Use knowledge of statistics on acceptance criteria, DOE and comparison testing to support manufacturing. engineers in the development of compliant test plans and reports. Support risk assessment processes for manufacturing and development including process FMEA and design FMEA, ensuring risk assessments are thorough and documentation meets all governing requirements. Support CAPA investigations, improvements, and effectiveness verification testing. Lead and/or support investigations of non-conforming product, materials, or processes through the coordination of cross functional teams while simultaneously.
Responsibilities
In this Sr Quality Systems Specialist for Operations Quality, you will have responsibility for the Quality and Compliance of process development. Manufacturing of implantable electronic products at our client Tempe Campus. Responsibilities may include the following and other duties may be assigned. Ensure internal quality processes, procedures and systems are compliant to all governing standards. Support manufacturing development and continuous improvement as the Quality team member for process development and validation including. Equipment Development, IQ, Process Characterization, OQPQ and Test Method Development and Validation. Use knowledge of statistics on acceptance criteria, DOE and comparison testing to support manufacturing. engineers in the development of compliant test plans and reports. Support risk assessment processes for manufacturing and development including process FMEA and design FMEA, ensuring risk assessments are thorough and documentation meets all governing requirements. Support CAPA investigations, improvements, and effectiveness verification testing. Lead and/or support investigations of non-conforming product, materials, or processes through the coordination of cross functional teams while simultaneously.
Requirements:
Bachelor's degree. Strong understanding of operations/manufacturing processes and products; Develop and support solutions for monitoring and reporting as well as taking appropriate action based on quality metrics. Ability to work independently and provide comprehensive feedback on complex issues, support risk assessment processes for manufacturing and development. Strong Communication Skills (verbal and written). Someone from the Medical Device or Medical Manufacturing industry is required. Seniority level
Seniority level Associate Employment type
Employment type Full-time Job function
Job function Quality Assurance Industries Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Katalyst CRO by 2x Get notified about new Senior Quality Engineer jobs in
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Sr Quality Engineer
role at
Katalyst CRO Join to apply for the
Sr Quality Engineer
role at
Katalyst CRO Get AI-powered advice on this job and more exclusive features. In this Sr Quality Systems Specialist for Operations Quality, you will have responsibility for the Quality and Compliance of process development. Manufacturing of implantable electronic products at our client Tempe Campus. Responsibilities may include the following and other duties may be assigned. Ensure internal quality processes, procedures and systems are compliant to all governing standards. Support manufacturing development and continuous improvement as the Quality team member for process development and validation including. Equipment Development, IQ, Process Characterization, OQPQ and Test Method Development and Validation. Use knowledge of statistics on acceptance criteria, DOE and comparison testing to support manufacturing. engineers in the development of compliant test plans and reports. Support risk assessment processes for manufacturing and development including process FMEA and design FMEA, ensuring risk assessments are thorough and documentation meets all governing requirements. Support CAPA investigations, improvements, and effectiveness verification testing. Lead and/or support investigations of non-conforming product, materials, or processes through the coordination of cross functional teams while simultaneously.
Responsibilities
In this Sr Quality Systems Specialist for Operations Quality, you will have responsibility for the Quality and Compliance of process development. Manufacturing of implantable electronic products at our client Tempe Campus. Responsibilities may include the following and other duties may be assigned. Ensure internal quality processes, procedures and systems are compliant to all governing standards. Support manufacturing development and continuous improvement as the Quality team member for process development and validation including. Equipment Development, IQ, Process Characterization, OQPQ and Test Method Development and Validation. Use knowledge of statistics on acceptance criteria, DOE and comparison testing to support manufacturing. engineers in the development of compliant test plans and reports. Support risk assessment processes for manufacturing and development including process FMEA and design FMEA, ensuring risk assessments are thorough and documentation meets all governing requirements. Support CAPA investigations, improvements, and effectiveness verification testing. Lead and/or support investigations of non-conforming product, materials, or processes through the coordination of cross functional teams while simultaneously.
Requirements:
Bachelor's degree. Strong understanding of operations/manufacturing processes and products; Develop and support solutions for monitoring and reporting as well as taking appropriate action based on quality metrics. Ability to work independently and provide comprehensive feedback on complex issues, support risk assessment processes for manufacturing and development. Strong Communication Skills (verbal and written). Someone from the Medical Device or Medical Manufacturing industry is required. Seniority level
Seniority level Associate Employment type
Employment type Full-time Job function
Job function Quality Assurance Industries Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Katalyst CRO by 2x Get notified about new Senior Quality Engineer jobs in
Tempe, AZ . Sr. Quality Engineer - Mission Assurance
Tempe, AZ $135,000.00-$175,000.00 6 hours ago Sr. Engineer, Supplier Quality Assurance (SQA)
Tempe, AZ $147,000.00-$272,500.00 1 week ago Mechanical Senior Project Engineer - Mission Critical Facilities
Chandler, AZ $102,100.00-$168,500.00 1 month ago Electrical Senior Project Engineer - Mission Critical Facilities
Chandler, AZ $102,100.00-$168,500.00 1 month ago Phoenix, AZ $86,460.00-$146,982.00 3 days ago Quality Engineer - NCQA (Mid-Level or Senior)
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Phoenix, AZ $158,000.00-$171,000.00 2 days ago Principal/Quality Engineer (Level 2 OR 3) - R10201671
Chandler, AZ $77,200.00-$142,900.00 1 week ago Quality Engineer I, Post Market Surveillance (PMS)
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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