Integer HoldingsPosted 1 week ago

Supplier Quality Engineer III

Integer HoldingsPosted 1 week ago

On-sitePalm Harbor, Florida, United States

Palm Harbor, Florida, United StatesOn-siteFull TimeLarge

Full TimeLarge

Job Summary

Manage supplier non-conformances, conduct audits, and lead product and process change notification systems to ensure customer expectations are met. Lead Supplier Quality Agreement management, oversee sourced item qualification, and execute First Article Inspection processes while monitoring KPIs and managing deviation guidance. Resolve acute quality problems by collaborating with suppliers, management, and manufacturing teams on root cause analysis, containment, and corrective actions. Support regulatory inspections, validate BOM changes, and drive continuous improvement initiatives aligned with site Hoshin Plans and 5 Sigma goals. Supervise up to three direct reports and mentor engineers while adhering to FDA regulations and Quality Management Systems.

Required Qualifications

Bachelor's degree in an engineering or related field
5+ years of progressive engineering and/or technically focused roles and experiences
10+ years of relevant experience (for candidates not meeting the education requirement)
6-Sigma green belt certification
Awareness of relevant Domestic and International Regulations and Industry Standards (e.g. ISO, QSR, UL, MDD, TGA etc.)
Good knowledge in Microsoft Office
Competencies in both written and oral communications
Competencies in both written and oral English communications (for outside of US countries)
Calm demeanor that transcends the high energy, constantly changing production environment
Positive, can-do attitude with an underlying belief that failure is not an option
Ability to be an effective contributor to a team or produce results of a technical nature as an individual
Adherence to all Integer Values: Customer, Integrity, Candor, Inclusion, Collaboration, Innovation
Active supporter of the Integer Environmental, Health & Safety programs
Defined Goals and Objectives specifying key projects and expected milestones to achieve
Ability to generate continuous improvement suggestions and support the implementation of them
Ability to manage supplier non-conformances
Ability to manage and conduct supplier audits
Ability to lead the suppliers' product and process change notification system
Ability to lead Supplier Quality Agreement management process with suppliers
Ability to work with Suppliers, Management, Supply Chain, Engineers and Manufacturing associates in the resolution of supplier quality problems
Ability to assist groups with capability studies and the application of statistical quality control which include Cpk, DOE, Hypotheses Testing
Ability to manage the sourced item qualification process
Ability to manage the First Article Inspection process
Ability to monitor supplier related KPIs
Ability to review the adequacy and correctness of changes to Bill of Materials (BOM's), Incoming Inspection Plans, Drawings, Component Specification, FMEAs
Ability to serve as a coach and mentor for other engineers
Ability to perform work on technical projects where you will follow Integer's standard quality management and production system methodologies
Ability to collaborate with others in the exchange of information, ask questions and regularly check for understanding
Ability to ensure that the disposition of supplier caused non-conforming materials meet all necessary procedures
Ability to lead site SCAR activities, including analysis of data and trends in supplier quality nonconforming material, bounding and containment, root cause analysis and effectiveness verification
Ability to support and lead internal quality audit activities
Ability to support regulatory and agency inspections, audits, investigations, and inquiries related to supplier quality
Ability to assure adherence to our Quality Management System (QMS)
Ability to support to corrective and preventive actions investigation and implementation
Ability to contribute to the successful attainment of our quality KPI's and journey to 5 Sigma
Ability to initiate and complete customer change notifications
Ability to support continuous improvement activities
Ability to adopt principles of built-in-quality
Ability to adopt standardized problem solving methodologies
Ability to adopt behavior-based safety programs
Ability to participate in improvement idea and suggestion systems
Ability to follow Integer's standard quality management and production system methodologies
Ability to investigate opportunities for product and process improvements
Ability to ensure that all appropriate documentation is completed
Ability to maintain liaison with individuals and units within or outside the organization
Ability to act independently on technical matters pertaining to their filed
Ability to adhere to Integer's Values and all safety, environmental, security and quality requirements including, but not limited to: Quality Management Systems (QMS), Safety, Environmental and Security Management Systems, U.S. Food and Drug Administration (FDA) regulations, company policies and operating procedures, and other regulatory requirements
Ability to apply intensive and diversified knowledge of engineering principles and practices in broad areas of assignments and related fields
Ability to identify and evaluate procedures to ensure the production of quality product
Ability to develop new and unique approaches to complex problems and can advance technology beyond previous achieved levels
Ability to apply engineering concepts to resolve acute or chronic problems
Ability to conduct studies to understand capability for process and/or measurement systems
Ability to provide management with technical guidance as required
Ability to identify and develop appropriate documentation for process improvement and project implementation
Ability to manage the team's quarterly review cycle
Ability to manage supplier related KPIs
Ability to assure compliance with DMR while providing deviation/waiver guidance and assuring complete and correct Device History Records are maintained
Ability to review the adequacy and correctness of changes to Bill of Materials (BOM's), Incoming Inspection Plans, Drawings, Component Specification, FMEAs, etc.
Ability to be a supplier quality resource for any site continuous improvement projects
Ability to support product transfers
Ability to provide supervision for up to 3 engineering direct reports
Ability to model the behaviors and disciplines of an engineering or technical professional
Ability to follow Integer's standard quality management and production system methodologies
Ability to investigate opportunities for product and process improvements
Ability to collaborate with others in the exchange of information, ask questions and regularly check for understanding
Ability to support Non-Conforming Material Process
Ability to ensure that the disposition of supplier caused non-conforming materials meet all necessary procedures
Ability to assure adequacy of supplier corrective actions to prevent re-occurrence
Ability to lead site SCAR activities, including analysis of data and trends in supplier quality nonconforming material, bounding and containment, root cause analysis and effectiveness verification
Ability to support and lead internal quality audit activities
Ability to support regulatory and agency inspections, audits, investigations, and inquiries related to supplier quality
Ability to assure adherence to our Quality Management System (QMS)
Ability to support to corrective and preventive actions investigation and implementation
Ability to contribute to the successful attainment of our quality KPI's and journey to 5 Sigma
Ability to initiate and complete customer change notifications
Ability to support continuous improvement activities
Ability to adopt principles of built-in-quality
Ability to adopt standardized problem solving methodologies
Ability to adopt behavior-based safety programs
Ability to participate in improvement idea and suggestion systems
Ability to follow Integer's standard quality management and production system methodologies
Ability to investigate opportunities for product and process improvements
Ability to collaborate with others in the exchange of information, ask questions and regularly check for understanding
Ability to ensure that all appropriate documentation is completed
Ability to maintain liaison with individuals and units within or outside the organization
Ability to act independently on technical matters pertaining to their filed
Ability to adhere to Integer's Values and all safety, environmental, security and quality requirements including, but not limited to: Quality Management Systems (QMS), Safety, Environmental and Security Management Systems, U.S. Food and Drug Administration (FDA) regulations, company policies and operating procedures, and other regulatory requirements
Ability to apply intensive and diversified knowledge of engineering principles and practices in broad areas of assignments and related fields
Ability to identify and evaluate procedures to ensure the production of quality product
Ability to develop new and unique approaches to complex problems and can advance technology beyond previous achieved levels
Ability to apply engineering concepts to resolve acute or chronic problems
Ability to conduct studies to understand capability for process and/or measurement systems
Ability to provide management with technical guidance as required
Ability to identify and develop appropriate documentation for process improvement and project implementation
Ability to manage the team's quarterly review cycle
Ability to manage supplier related KPIs
Ability to assure compliance with DMR while providing deviation/waiver guidance and assuring complete and correct Device History Records are maintained
Ability to review the adequacy and correctness of changes to Bill of Materials (BOM's), Incoming Inspection Plans, Drawings, Component Specification, FMEAs, etc.
Ability to be a supplier quality resource for any site continuous improvement projects
Ability to support product transfers
Ability to provide supervision for up to 3 engineering direct reports
Ability to model the behaviors and disciplines of an engineering or technical professional
Ability to follow Integer's standard quality management and production system methodologies
Ability to investigate opportunities for product and process improvements
Ability to collaborate with others in the exchange of information, ask questions and regularly check for understanding
Ability to support Non-Conforming Material Process
Ability to ensure that the disposition of supplier caused non-conforming materials meet all necessary procedures
Ability to assure adequacy of supplier corrective actions to prevent re-occurrence
Ability to lead site SCAR activities, including analysis of data and trends in supplier quality nonconforming material, bounding and containment, root cause analysis and effectiveness verification
Ability to support and lead internal quality audit activities
Ability to support regulatory and agency inspections, audits, investigations, and inquiries related to supplier quality
Ability to assure adherence to our Quality Management System (QMS)
Ability to support to corrective and preventive actions investigation and implementation
Ability to contribute to the successful attainment of our quality KPI's and journey to 5 Sigma
Ability to initiate and complete customer change notifications
Ability to support continuous improvement activities
Ability to adopt principles of built-in-quality
Ability to adopt standardized problem solving methodologies
Ability to adopt behavior-based safety programs
Ability to participate in improvement idea and suggestion systems
Ability to follow Integer's standard quality management and production system methodologies
Ability to investigate opportunities for product and process improvements
Ability to collaborate with others in the exchange of information, ask questions and regularly check for understanding
Ability to ensure that all appropriate documentation is completed
Ability to maintain liaison with individuals and units within or outside the organization
Ability to act independently on technical matters pertaining to their filed
Ability to adhere to Integer's Values and all safety, environmental, security and quality requirements including, but not limited to: Quality Management Systems (QMS), Safety, Environmental and Security Management Systems, U.S. Food and Drug Administration (FDA) regulations, company policies and operating procedures, and other regulatory requirements
Ability to apply intensive and diversified knowledge of engineering principles and practices in broad areas of assignments and related fields
Ability to identify and evaluate procedures to ensure the production of quality product
Ability to develop new and unique approaches to complex problems and can advance technology beyond previous achieved levels
Ability to apply engineering concepts to resolve acute or chronic problems
Ability to conduct studies to understand capability for process and/or measurement systems
Ability to provide management with technical guidance as required
Ability to identify and develop appropriate documentation for process improvement and project implementation
Ability to manage the team's quarterly review cycle
Ability to manage supplier related KPIs
Ability to assure compliance with DMR while providing deviation/waiver guidance and assuring complete and correct Device History Records are maintained
Ability to review the adequacy and correctness of changes to Bill of Materials (BOM's), Incoming Inspection Plans, Drawings, Component Specification, FMEAs, etc.
Ability to be a supplier quality resource for any site continuous improvement projects
Ability to support product transfers
Ability to provide supervision for up to 3 engineering direct reports
Ability to model the behaviors and disciplines of an engineering or technical professional
Ability to follow Integer's standard quality management and production system methodologies
Ability to investigate opportunities for product and process improvements
Ability to collaborate with others in the exchange of information, ask questions and regularly check for understanding
Ability to support Non-Conforming Material Process
Ability to ensure that the disposition of supplier caused non-conforming materials meet all necessary procedures
Ability to assure adequacy of supplier corrective actions to prevent re-occurrence
Ability to lead site SCAR activities, including analysis of data and trends in supplier quality nonconforming material, bounding and containment, root cause analysis and effectiveness verification
Ability to support and lead internal quality audit activities
Ability to support regulatory and agency inspections, audits, investigations, and inquiries related to supplier quality
Ability to assure adherence to our Quality Management System (QMS)
Ability to support to corrective and preventive actions investigation and implementation
Ability to contribute to the successful attainment of our quality KPI's and journey to 5 Sigma
Ability to initiate and complete customer change notifications
Ability to support continuous improvement activities
Ability to adopt principles of built-in-quality
Ability to adopt standardized problem solving methodologies
Ability to adopt behavior-based safety programs
Ability to participate in improvement idea and suggestion systems
Ability to follow Integer's standard quality management and production system methodologies
Ability to investigate opportunities for product and process improvements
Ability to collaborate with others in the exchange of information, ask questions and regularly check for understanding
Ability to ensure that all appropriate documentation is completed
Ability to maintain liaison with individuals and units within or outside the organization
Ability to act independently on technical matters pertaining to their filed
Ability to adhere to Integer's Values and all safety, environmental, security and quality requirements including, but not limited to: Quality Management Systems (QMS), Safety, Environmental and Security Management Systems, U.S. Food and Drug Administration (FDA) regulations, company policies and operating procedures, and other regulatory requirements
Ability to apply intensive and diversified knowledge of engineering principles and practices in broad areas of assignments and related fields
Ability to identify and evaluate procedures to ensure the production of quality product
Ability to develop new and unique approaches to complex problems and can advance technology beyond previous achieved levels
Ability to apply engineering concepts to resolve acute or chronic problems
Ability to conduct studies to understand capability for process and/or measurement systems
Ability to provide management with technical guidance as required
Ability to identify and develop appropriate documentation for process improvement and project implementation
Ability to manage the team's quarterly review cycle
Ability to manage supplier related KPIs
Ability to assure compliance with DMR while providing deviation/waiver guidance and assuring complete and correct Device History Records are maintained
Ability to review the adequacy and correctness of changes to Bill of Materials (BOM's), Incoming Inspection Plans, Drawings, Component Specification, FMEAs, etc.
Ability to be a supplier quality resource for any site continuous improvement projects
Ability to support product transfers
Ability to provide supervision for up to 3 engineering direct reports
Ability to model the behaviors and disciplines of an engineering or technical professional
Ability to follow Integer's standard quality management and production system methodologies
Ability to investigate opportunities for product and process improvements
Ability to collaborate with others in the exchange of information, ask questions and regularly check for understanding
Ability to support Non-Conforming Material Process
Ability to ensure that the disposition of supplier caused non-conforming materials meet all necessary procedures
Ability to assure adequacy of supplier corrective actions to prevent re-occurrence
Ability to lead site SCAR activities, including analysis of data and trends in supplier quality nonconforming material, bounding and containment, root cause analysis and effectiveness verification
Ability to support and lead internal quality audit activities
Ability to support regulatory and agency inspections, audits, investigations, and inquiries related to supplier quality
Ability to assure adherence to our Quality Management System (QMS)
Ability to support to corrective and preventive actions investigation and implementation
Ability to contribute to the successful attainment of our quality KPI's and journey to 5 Sigma
Ability to initiate and complete customer change notifications
Ability to support continuous improvement activities
Ability to adopt principles of built-in-quality
Ability to adopt standardized problem solving methodologies
Ability to adopt behavior-based safety programs
Ability to participate in improvement idea and suggestion systems
Ability to follow Integer's standard quality management and production system methodologies
Ability to investigate opportunities for product and process improvements
Ability to collaborate with others in the exchange of information, ask questions and regularly check for understanding
Ability to ensure that all appropriate documentation is completed
Ability to maintain liaison with individuals and units within or outside the organization
Ability to act independently on technical matters pertaining to their filed
Ability to adhere to Integer's Values and all safety, environmental, security and quality requirements including, but not limited to: Quality Management Systems (QMS), Safety, Environmental and Security Management Systems, U.S. Food and Drug Administration (FDA) regulations, company policies and operating procedures, and other regulatory requirements
Ability to apply intensive and diversified knowledge of engineering principles and practices in broad areas of assignments and related fields
Ability to identify and evaluate procedures to ensure the production of quality product
Ability to develop new and unique approaches to complex problems and can advance technology beyond previous achieved levels
Ability to apply engineering concepts to resolve acute or chronic problems
Ability to conduct studies to understand capability for process and/or measurement systems
Ability to provide management with technical guidance as required
Ability to identify and develop appropriate documentation for process improvement and project implementation
Ability to manage the team's quarterly review cycle
Ability to manage supplier related KPIs
Ability to assure compliance with DMR while providing deviation/waiver guidance and assuring complete and correct Device History Records are maintained
Ability to review the adequacy and correctness of changes to Bill of Materials (BOM's), Incoming Inspection Plans, Drawings, Component Specification, FMEAs, etc.
Ability to be a supplier quality resource for any site continuous improvement projects
Ability to support product transfers
Ability to provide supervision for up to 3 engineering direct reports
Ability to model the behaviors and disciplines of an engineering or technical professional
Ability to follow Integer's standard quality management and production system methodologies

Hiring someone like this?

Get your role in front of qualified candidates on Sorce.

Get started