Katalyst CRO
Sr. Quality Engineer
Katalyst CRO - Tempe, Arizona, us, 85285
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Overview
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Overview
Join to apply for the
Sr. Quality Engineer
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Katalyst CRO 8 months ago Be among the first 25 applicants Join to apply for the
Sr. Quality Engineer
role at
Katalyst CRO Strong background in IQ, Process Characterization, OQPQ, and Test Method Development and Validation Strong understanding of regulatory requirements (i.e.: ISO, FDA-GMP, etc.) Strong understanding of medical device manufacturing processes and products
Top 3 Skills
Strong background in IQ, Process Characterization, OQPQ, and Test Method Development and Validation Strong understanding of regulatory requirements (i.e.: ISO, FDA-GMP, etc.) Strong understanding of medical device manufacturing processes and products
Education Required: Bachelor's degree in engineering or technical discipline
Years' Experience Required: 4+ years of engineering experience in a medical device manufacturing environment
Description
In this Senior Quality Engineer for Operations Quality, you will have responsibility for the Quality and Compliance of process development and manufacturing of implantable electronic products at client's Tempe Campus.
Responsibilities
The Sr. Manufacturing Quality Engineer is responsible for documentation of the non-conformances, identification of population, containment of population, and communication of non-conformance to applicable parties. 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. Work with the customer and local Design teams to ensure appropriate Design Outputs have been provided to the manufacturing team that enable high product quality via Process and Test Method Validations. 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. Develop and support solutions for monitoring and reporting as well as taking appropriate action based on quality metrics; which includes performance scorecards, issue reporting and other performance measures. 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 performing the role of Quality Engineer. Independently provide comprehensive technical solutions for complex issues related to quality processes, procedures, and systems to meet organizational objectives. Facilitate group meetings and project leadership that drives comprehensive technical solutions for multiple issues and projects simultaneously Communicate clearly regarding technical issues and solutions
Duties
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
Must Haves
Strong background in Equipment Development, IQ, Process Characterization, OQ/PQ, and Test Method Development and Validation. Strong understanding of regulatory requirements (i.e.: ISO, FDA-GMP, etc.) Strong Client, CAPA and investigation experience Strong understanding of product/process risk management (D/PFMEAs)
Nice To Haves
Experience with electronics manufacturing including wafer fabs and electronicsassembly. Six Sigma or DRM certification Strong statistical analysis techniques Seniority level
Seniority level Entry level Employment type
Employment type Contract 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 8 months ago Be among the first 25 applicants Join to apply for the
Sr. Quality Engineer
role at
Katalyst CRO Strong background in IQ, Process Characterization, OQPQ, and Test Method Development and Validation Strong understanding of regulatory requirements (i.e.: ISO, FDA-GMP, etc.) Strong understanding of medical device manufacturing processes and products
Top 3 Skills
Strong background in IQ, Process Characterization, OQPQ, and Test Method Development and Validation Strong understanding of regulatory requirements (i.e.: ISO, FDA-GMP, etc.) Strong understanding of medical device manufacturing processes and products
Education Required: Bachelor's degree in engineering or technical discipline
Years' Experience Required: 4+ years of engineering experience in a medical device manufacturing environment
Description
In this Senior Quality Engineer for Operations Quality, you will have responsibility for the Quality and Compliance of process development and manufacturing of implantable electronic products at client's Tempe Campus.
Responsibilities
The Sr. Manufacturing Quality Engineer is responsible for documentation of the non-conformances, identification of population, containment of population, and communication of non-conformance to applicable parties. 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. Work with the customer and local Design teams to ensure appropriate Design Outputs have been provided to the manufacturing team that enable high product quality via Process and Test Method Validations. 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. Develop and support solutions for monitoring and reporting as well as taking appropriate action based on quality metrics; which includes performance scorecards, issue reporting and other performance measures. 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 performing the role of Quality Engineer. Independently provide comprehensive technical solutions for complex issues related to quality processes, procedures, and systems to meet organizational objectives. Facilitate group meetings and project leadership that drives comprehensive technical solutions for multiple issues and projects simultaneously Communicate clearly regarding technical issues and solutions
Duties
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
Must Haves
Strong background in Equipment Development, IQ, Process Characterization, OQ/PQ, and Test Method Development and Validation. Strong understanding of regulatory requirements (i.e.: ISO, FDA-GMP, etc.) Strong Client, CAPA and investigation experience Strong understanding of product/process risk management (D/PFMEAs)
Nice To Haves
Experience with electronics manufacturing including wafer fabs and electronicsassembly. Six Sigma or DRM certification Strong statistical analysis techniques Seniority level
Seniority level Entry level Employment type
Employment type Contract 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 . Tempe, AZ $147,000.00-$272,500.00 2 weeks ago Tempe, AZ $88,600.00-$181,900.00 2 hours ago Gilbert, AZ $88,600.00-$181,900.00 1 week ago Mechanical Senior Project Engineer - Mission Critical Facilities
Chandler, AZ $102,100.00-$168,500.00 2 weeks ago Electrical Senior Project Engineer - Mission Critical Facilities
Chandler, AZ $102,100.00-$168,500.00 2 weeks ago Phoenix, AZ $101,000.00-$203,000.00 20 hours ago Quality Engineer (Must Have Exp Quality Notifications, Complaints)
Sr. Quality Engineer - Mission Assurance
Tempe, AZ $135,000.00-$175,000.00 2 weeks 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