What are the responsibilities and job description for the Sr. Quality Engineer position at Kaygen Inc.?
KAYGEN is an emerging leader in providing top talent for technology based staffing services. We specialize in providing high-volume contingent staffing, direct hire staffing and project based solutions to companies worldwide ranging from startups to Fortune 500 and Managed Service Providers (MSP) across a wide variety of industries
There is a possibility of contract to hire
Hybrid position with at least 3 days onsite at San Jose, CA
Sr. Quality Engineer
The Sr. Quality Engineer is accountable for quality support for products developed and process design to achieve these goals through active participation and contribution to multifunctional and multi-divisional teams. The incumbent will be capable of self- direction and project management to ensure successful outcomes. The Sr. Quality Engineer is accountable for supporting new product development and/or product sustaining activities through the application of Quality engineering skills for medical devices. For Sustaining Product activities, this person will understand, improve, and control operational processes in order to realize predictable product flow while satisfying established client standards of quality. Successful performance requires close work with quality management, operations, suppliers and/or client associates to assure compliance with all client quality policies, procedures, and practices.
Primary Duties and Responsibilities:
Provide guidance and Quality oversight to ensure establishment and execution of sustaining programs aligned with regulatory requirements and industry standards.
Support new product design transfer activities and existing product sustaining activities to ensure work follows proper design
control. Ensure controls meet Client and FDA regulatory requirements by actively participating on product development
teams and identifying Quality needs, product improvements and customer requirements.
Ensures adequate design control documentation and records are maintained to support life cycle of design history.
Provide support for each aspect of design control and ensure tasks are completed adequately to include project
planning, design inputs, critical to quality characteristics, risk analysis, design reviews, validations, verifications, and
design history files and other activities as needed.
Ensures the design is appropriately specified and established before transferring into manufacturing to avoid increased risk.
Review and authorize Quality approval for device design specifications including product performance specifications, test methods, acceptance criteria, and release.
Support product and/or device shipping studies by providing quality and regulatory requirements, approving protocols, assessing generated data and approving final reports.
Review and assess work performed by R&D and other Client business units to help ensure Quality issues with device(s) or component(s) are adequately addressed and when needed corrective actions are taken to prevent recurring quality issues.
Work with Validation team providing Quality Engineering support for Product and/or Device transfer, Scale-Up, and
Process Validation.
Lead or participate in Risk Management activities appropriate to the initiative or situation.
Monitor quality data from complaints process, Manufacturing reports, Service reports and customer input. Identifies, investigates, troubleshoots and resolves identified quality issues independently or by working with Manufacturing, Service, Engineering, Regulatory and Biostatics.
Initiate Corrective and Preventative Action plans and perform efficacy follow up.
Support Regulatory Affairs, as appropriate, by providing input for submissions or response to agency queries. Support regulatory inspections as needed.
Lead situation analysis and support activities relating to Field Corrective Actions, when needed.
Work collaboratively and cross functionally to improve product performance. Utilize trouble shooting and problem solving skills to identify and eliminate issues that negatively impact product performance
Education and Experience:
Bachelors degree in Science, Engineering, or other relevant field and 5 years relevant experience within a Quality function and working in a FDA or ISO regulated environment.
Certified Quality Engineering (CQE) preferred.
Robust understanding of QSR, Design Control, ISO, Product Risk Management and GMPs as defined in CFR 820 and of industry standards but not limited to Green belt and Design for Six Sigma methodology and tools.
Excellent people interaction, team building, and communication skills. Problem solving skills with experience in project management to include organization, prioritization, problem solving, and sound judgment are critical. Understanding of statistical analysis
At KAYGEN, we are always looking for dynamic, talented and experienced individuals. We invite you to join our team of talented IT professionals, consulting at client locations across the globe. Our culture is team-orientated; we strive to stand by our core values of respect, honesty and integrity. Our team of experienced staffing experts will work with you to find you the best opportunity. For more information please visit us at (url removed).
There is a possibility of contract to hire
Hybrid position with at least 3 days onsite at San Jose, CA
Sr. Quality Engineer
The Sr. Quality Engineer is accountable for quality support for products developed and process design to achieve these goals through active participation and contribution to multifunctional and multi-divisional teams. The incumbent will be capable of self- direction and project management to ensure successful outcomes. The Sr. Quality Engineer is accountable for supporting new product development and/or product sustaining activities through the application of Quality engineering skills for medical devices. For Sustaining Product activities, this person will understand, improve, and control operational processes in order to realize predictable product flow while satisfying established client standards of quality. Successful performance requires close work with quality management, operations, suppliers and/or client associates to assure compliance with all client quality policies, procedures, and practices.
Primary Duties and Responsibilities:
Provide guidance and Quality oversight to ensure establishment and execution of sustaining programs aligned with regulatory requirements and industry standards.
Support new product design transfer activities and existing product sustaining activities to ensure work follows proper design
control. Ensure controls meet Client and FDA regulatory requirements by actively participating on product development
teams and identifying Quality needs, product improvements and customer requirements.
Ensures adequate design control documentation and records are maintained to support life cycle of design history.
Provide support for each aspect of design control and ensure tasks are completed adequately to include project
planning, design inputs, critical to quality characteristics, risk analysis, design reviews, validations, verifications, and
design history files and other activities as needed.
Ensures the design is appropriately specified and established before transferring into manufacturing to avoid increased risk.
Review and authorize Quality approval for device design specifications including product performance specifications, test methods, acceptance criteria, and release.
Support product and/or device shipping studies by providing quality and regulatory requirements, approving protocols, assessing generated data and approving final reports.
Review and assess work performed by R&D and other Client business units to help ensure Quality issues with device(s) or component(s) are adequately addressed and when needed corrective actions are taken to prevent recurring quality issues.
Work with Validation team providing Quality Engineering support for Product and/or Device transfer, Scale-Up, and
Process Validation.
Lead or participate in Risk Management activities appropriate to the initiative or situation.
Monitor quality data from complaints process, Manufacturing reports, Service reports and customer input. Identifies, investigates, troubleshoots and resolves identified quality issues independently or by working with Manufacturing, Service, Engineering, Regulatory and Biostatics.
Initiate Corrective and Preventative Action plans and perform efficacy follow up.
Support Regulatory Affairs, as appropriate, by providing input for submissions or response to agency queries. Support regulatory inspections as needed.
Lead situation analysis and support activities relating to Field Corrective Actions, when needed.
Work collaboratively and cross functionally to improve product performance. Utilize trouble shooting and problem solving skills to identify and eliminate issues that negatively impact product performance
Education and Experience:
Bachelors degree in Science, Engineering, or other relevant field and 5 years relevant experience within a Quality function and working in a FDA or ISO regulated environment.
Certified Quality Engineering (CQE) preferred.
Robust understanding of QSR, Design Control, ISO, Product Risk Management and GMPs as defined in CFR 820 and of industry standards but not limited to Green belt and Design for Six Sigma methodology and tools.
Excellent people interaction, team building, and communication skills. Problem solving skills with experience in project management to include organization, prioritization, problem solving, and sound judgment are critical. Understanding of statistical analysis
At KAYGEN, we are always looking for dynamic, talented and experienced individuals. We invite you to join our team of talented IT professionals, consulting at client locations across the globe. Our culture is team-orientated; we strive to stand by our core values of respect, honesty and integrity. Our team of experienced staffing experts will work with you to find you the best opportunity. For more information please visit us at (url removed).
Sr Principal Quality Engineer
FormFactor, Inc. -
Livermore, CA
Sr Quality Engineer
Imperative Care Inc -
Campbell, CA
Sr. Product Quality Engineer, Imaging
Noah Medical -
San Carlos, CA
