Sr Quality Engineer
Apply NowCompany: Artech LLC
Location: Tempe, AZ 85281
Description:
Job Title: Sr Quality Engineer
Job ID: 17415
Location: 2350 West Client Way Tempe Arizona 85281
Duration: 12 months
Pay Range: $60.00-65.00/hr
JOB DESCRIPTION:
Must Have
Strong background in Equipment Development, IQ, Process Characterization, OQPQ, and Test Method Development and Validation.
Strong understanding of regulatory requirements (i.e.: ISO, FDA-GMP, etc.)
Nice To Have
Experience with electronics manufacturing including wafer fabs and electronics assembly.
Six Sigma or DRM certification
Strong statistical analysis techniques
In this Sr Quality Systems Specialist 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 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
Top 3 technical skills that are required for the role:
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)
Education Required: Bachelor's degree
Years' Experience Required: 4+ years' work experience
Will the contractor be working 40 hours a week? If not, weekly estimate? 40 hours per week
Does this position require the candidate to be onsite or remote, if hybrid what does the onsite vs remote schedule look like? Onsite
What is your timeline for scheduling interviews? Week of March 17, 2025
What product line will this person support? Wafer and Sensor Operations and Hybrid product lines
Responsibilities may include the following and other duties may be assigned. Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product. Collaborates with engineering and manufacturing functions to ensure quality standards are in place. Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment. Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications. Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements. May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.
A Day in the Life
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.
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. The Principal Manufacturing Quality Engineer irresponsible for documentation of the non-conformances, identification of
population, containment of population, and communication of non-conformance to applicable parties.
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
Thank you
Ashwini Nair
Job ID: 17415
Location: 2350 West Client Way Tempe Arizona 85281
Duration: 12 months
Pay Range: $60.00-65.00/hr
JOB DESCRIPTION:
Must Have
Strong background in Equipment Development, IQ, Process Characterization, OQPQ, and Test Method Development and Validation.
Strong understanding of regulatory requirements (i.e.: ISO, FDA-GMP, etc.)
Nice To Have
Experience with electronics manufacturing including wafer fabs and electronics assembly.
Six Sigma or DRM certification
Strong statistical analysis techniques
In this Sr Quality Systems Specialist 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 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
Top 3 technical skills that are required for the role:
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)
Education Required: Bachelor's degree
Years' Experience Required: 4+ years' work experience
Will the contractor be working 40 hours a week? If not, weekly estimate? 40 hours per week
Does this position require the candidate to be onsite or remote, if hybrid what does the onsite vs remote schedule look like? Onsite
What is your timeline for scheduling interviews? Week of March 17, 2025
What product line will this person support? Wafer and Sensor Operations and Hybrid product lines
Responsibilities may include the following and other duties may be assigned. Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product. Collaborates with engineering and manufacturing functions to ensure quality standards are in place. Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment. Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications. Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements. May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.
A Day in the Life
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.
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. The Principal Manufacturing Quality Engineer irresponsible for documentation of the non-conformances, identification of
population, containment of population, and communication of non-conformance to applicable parties.
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
Thank you
Ashwini Nair