Sr Quality Engineer - Exempt - LanceSoft Inc
Tempe, AZ 85281
About the Job
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 electronicsassembly.
Six Sigma or DRM certification
Strong statistical analysis techniques
JOB 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 ***’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 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
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? within the next 7 days from job posting distribution
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. SPECIALIST CAREER STREAM: Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University). DIFFERENTIATING FACTORS Autonomy: Seasoned individual contributor. Works independently under limited supervision to determine and develop approach to solutions. Coaches and reviews the work of lower level specialists; may manage projects / processes. Organizational Impact: May be responsible for entire projects or processes within job area. Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments. Innovation and Complexity: Problems and issues faced are difficult, and may require understanding of multiple issues, job areas or specialties . Makes improvements of processes, systems or products to enhance performance of the job area. Analysis provided is indepth in nature and often provides recommendations on process improvements. Communication and Influence: Communicates with senior internal and external customers and vendors. Exchange information of facts, statuses, ideas and issues to achieve objective, and influence decisionmaking. Leadership and Talent Management: May provide guidance, coaching and training to other employees within job area. May manage projects, requiring delegation of work and review of others' work product . Required Knowledge and Experience: Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience. May have practical knowledge of project management. Requires a University Degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.
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 allgoverning standards.
• Support manufacturing development and continuous improvement as the Qualityteam member for process development and validation including EquipmentDevelopment, IQ, Process Characterization, OQPQ and Test Method Developmentand Validation.
• Use knowledge of statistics on acceptance criteria, DOE and comparison testing tosupport manufacturing engineers in the development of compliant test plans andreports.
• Work with the customer and local Design teams to ensure appropriate DesignOutputs have been provided to the manufacturing team that enable high productquality via Process and Test Method Validations.
• Support risk assessment processes for manufacturing and development includingprocess FMEA and design FMEA, ensuring risk assessments are thorough anddocumentation meets all governing requirements.
• Develop and support solutions for monitoring and reporting as well as takingappropriate 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, orprocesses through the coordination of cross functional teams while simultaneouslyperforming the role of Quality Engineer. The Principal Manufacturing QualityEngineer is responsible 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 relatedto quality processes, procedures, and systems to meet organizational objectives.
• Facilitate group meetings and project leadership that drives comprehensive technicalsolutions for multiple issues and projects simultaneously
• Communicate clearly regarding technical issues and solutions
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 electronicsassembly.
Six Sigma or DRM certification
Strong statistical analysis techniques
JOB 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 ***’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 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
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? within the next 7 days from job posting distribution
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. SPECIALIST CAREER STREAM: Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University). DIFFERENTIATING FACTORS Autonomy: Seasoned individual contributor. Works independently under limited supervision to determine and develop approach to solutions. Coaches and reviews the work of lower level specialists; may manage projects / processes. Organizational Impact: May be responsible for entire projects or processes within job area. Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments. Innovation and Complexity: Problems and issues faced are difficult, and may require understanding of multiple issues, job areas or specialties . Makes improvements of processes, systems or products to enhance performance of the job area. Analysis provided is indepth in nature and often provides recommendations on process improvements. Communication and Influence: Communicates with senior internal and external customers and vendors. Exchange information of facts, statuses, ideas and issues to achieve objective, and influence decisionmaking. Leadership and Talent Management: May provide guidance, coaching and training to other employees within job area. May manage projects, requiring delegation of work and review of others' work product . Required Knowledge and Experience: Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience. May have practical knowledge of project management. Requires a University Degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.
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 allgoverning standards.
• Support manufacturing development and continuous improvement as the Qualityteam member for process development and validation including EquipmentDevelopment, IQ, Process Characterization, OQPQ and Test Method Developmentand Validation.
• Use knowledge of statistics on acceptance criteria, DOE and comparison testing tosupport manufacturing engineers in the development of compliant test plans andreports.
• Work with the customer and local Design teams to ensure appropriate DesignOutputs have been provided to the manufacturing team that enable high productquality via Process and Test Method Validations.
• Support risk assessment processes for manufacturing and development includingprocess FMEA and design FMEA, ensuring risk assessments are thorough anddocumentation meets all governing requirements.
• Develop and support solutions for monitoring and reporting as well as takingappropriate 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, orprocesses through the coordination of cross functional teams while simultaneouslyperforming the role of Quality Engineer. The Principal Manufacturing QualityEngineer is responsible 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 relatedto quality processes, procedures, and systems to meet organizational objectives.
• Facilitate group meetings and project leadership that drives comprehensive technicalsolutions for multiple issues and projects simultaneously
• Communicate clearly regarding technical issues and solutions
Source : LanceSoft Inc