Overview
On Site
Up to $80,000
Full Time
100% Travel
Skills
Analytical Skill
Auditing
Change Control
Change Management
Collaboration
Communication
Conflict Resolution
Continuous Improvement
Corrective And Preventive Action
Critical Thinking
FMEA
Fluency
GD&T
ISO 13485
KPI
Management
Manufacturing
Medical Devices
Negotiations
PPAP
Presentations
Problem Solving
Process Control
Program Management
Project Management
Quality Assurance
ROOT
Reporting
Risk Management
Sourcing
Statistical Process Control
Statistics
Strategic Sourcing
System Requirements
Regulatory Compliance
Job Details
Supplier Quality Engineer
Job Details
Id
511298
Title
Supplier Quality Engineer
Legal Entity
Location: Gainesville (CSLS0310), Florida
Office Location
Gainesville (CSLS0310), Florida
Employment Type
Full-time
Employee Type
Salaried
External Description
Job Description & Skill Requirement:
Knowledge of application of Regulatory requirement including ISO 13485, FDA and International
requirements
Enhanced quality system requirements (QSR) throughout business unit by improving quality
process and CAPA Closure
Implementing SICR- Supplier Initiated Change Requests (DCR, ECR, MCR) through Change
management Process and as per ISO 13485 & CFR 21 Part 820 requirements
Presenting Supplier Initiated Change Requests to Change Management Board (CMB) for review &
Approval
Review and Closure of Supplier Audit Non-Conformities as per NC & CAPA management System
(Track wise)
Review of Supplier deliverables like MSA, SPC, GD&T, Process Validation, PPAP, FMEA etc.
Conducting Supplier's Pre-Assessment Audits with Sourcing & RAQA Leads.
Implementing Change Control Agreement (CCA), Audit Adoption, Self-Assessment Audit and
Onsite Audit through organization procedure
Collaborates with cross-functional and suppliers' teams to address top quality issues.
Own identified supplier driven non-conformances and manage the timely closure of NC's within
Trackwise.
Own or support identified supplier CAPAs and manage to timely root cause investigation,
implementation and closure.
Communicate & collaborate with suppliers regarding non-conformances, escalating supplier
corrective action requests as required.
Participates and may lead in the creation and/or review of new or modified procedures.
Maintain KPIs for monitoring of supplier quality processes, perform analysis, and interpret trends,
identifying and activating on appropriate actions as necessary.
Applies statistical methods of analysis and process control to external operations.
Support manufacturing transfers to/from other plants/facilities, executing appropriate quality
activities.
Lead quality issues with suppliers & partner with Internal Customers; Lead effective supplier
containment and corrections/corrective actions
Act as point of contact for Internal/ External Customer groups on key compliance issues related to
assigned suppliers
Responsible for accuracy and integrity of supplier data that ensures compliance with documented
procedures & processes.
Ownership and reporting on all quality issues associated with the assigned suppliers. Ensure all
assigned supplier related material quality issues are effectively communicated to key stakeholders.
Maintain structured communication channels with strategic sourcing, identifying responsibility by
commodity / supplier.
Deliver continuous improvement activities focusing on supplier quality.
Participate in supplier audit program - planning, execution and closure.
Partner with SQM functions and Strategic Sourcing on the developments and approval quality
assurance agreements with suppliers.
Ability to collaborate effectively with lead cross functional team
Qualification:
Bachelor's Degree in Engineering or Science-related field
5+ years' experience in quality, engineering, manufacturing, or highly regulated environment
Fluent in written, oral in English and
Understanding of US and International Medical Device Regulations.
Strong knowledge of Quality Concepts (e.g. Risk Management, NC/CAPA, Audits, Statistics).
Must possess strong communication, project management and influencing skills as well as have
the ability to manage multiple tasks simultaneously.
Strong interpersonal skills, written, oral communication and negotiations skills.
Strong in critical thinking and "outside the box" thinking.
Highly developed problem-solving skills. Strong analytical skills.
Demonstrated ability to work independently and as part of cross-functional teams
French
Knowledge of application of Regulatory requirement including ISO 13485, FDA and International
requirements
Enhanced quality system requirements (QSR) throughout business unit by improving quality
process and CAPA Closure
Implementing SICR- Supplier Initiated Change Requests (DCR, ECR, MCR) through Change
management Process and as per ISO 13485 & CFR 21 Part 820 requirements
Presenting Supplier Initiated Change Requests to Change Management Board (CMB) for review &
Approval
Review and Closure of Supplier Audit Non-Conformities as per NC & CAPA management System
(Track wise)
Review of Supplier deliverables like MSA, SPC, GD&T, Process Validation, PPAP, FMEA etc.
Conducting Supplier's Pre-Assessment Audits with Sourcing & RAQA Leads.
Implementing Change Control Agreement (CCA), Audit Adoption, Self-Assessment Audit and
Onsite Audit through organization procedure
Collaborates with cross-functional and suppliers' teams to address top quality issues.
Own identified supplier driven non-conformances and manage the timely closure of NC's within
Trackwise.
Own or support identified supplier CAPAs and manage to timely root cause investigation,
implementation and closure.
Communicate & collaborate with suppliers regarding non-conformances, escalating supplier
corrective action requests as required.
Participates and may lead in the creation and/or review of new or modified procedures.
Maintain KPIs for monitoring of supplier quality processes, perform analysis, and interpret trends,
identifying and activating on appropriate actions as necessary.
Applies statistical methods of analysis and process control to external operations.
Support manufacturing transfers to/from other plants/facilities, executing appropriate quality
activities.
Lead quality issues with suppliers & partner with Internal Customers; Lead effective supplier
containment and corrections/corrective actions
Act as point of contact for Internal/ External Customer groups on key compliance issues related to
assigned suppliers
Responsible for accuracy and integrity of supplier data that ensures compliance with documented
procedures & processes.
Ownership and reporting on all quality issues associated with the assigned suppliers. Ensure all
assigned supplier related material quality issues are effectively communicated to key stakeholders.
Maintain structured communication channels with strategic sourcing, identifying responsibility by
commodity / supplier.
Deliver continuous improvement activities focusing on supplier quality.
Participate in supplier audit program - planning, execution and closure.
Partner with SQM functions and Strategic Sourcing on the developments and approval quality
assurance agreements with suppliers.
Ability to collaborate effectively with lead cross functional team
Qualification:
Bachelor's Degree in Engineering or Science-related field
5+ years' experience in quality, engineering, manufacturing, or highly regulated environment
Fluent in written, oral in English and
Understanding of US and International Medical Device Regulations.
Strong knowledge of Quality Concepts (e.g. Risk Management, NC/CAPA, Audits, Statistics).
Must possess strong communication, project management and influencing skills as well as have
the ability to manage multiple tasks simultaneously.
Strong interpersonal skills, written, oral communication and negotiations skills.
Strong in critical thinking and "outside the box" thinking.
Highly developed problem-solving skills. Strong analytical skills.
Demonstrated ability to work independently and as part of cross-functional teams
French
External Skills And Expertise
Job Description & Skill Requirement:
Knowledge of application of Regulatory requirement including ISO 13485, FDA and International
requirements
Enhanced quality system requirements (QSR) throughout business unit by improving quality
process and CAPA Closure
Implementing SICR- Supplier Initiated Change Requests (DCR, ECR, MCR) through Change
management Process and as per ISO 13485 & CFR 21 Part 820 requirements
Presenting Supplier Initiated Change Requests to Change Management Board (CMB) for review &
Approval
Review and Closure of Supplier Audit Non-Conformities as per NC & CAPA management System
(Track wise)
Review of Supplier deliverables like MSA, SPC, GD&T, Process Validation, PPAP, FMEA etc.
Conducting Supplier's Pre-Assessment Audits with Sourcing & RAQA Leads.
Implementing Change Control Agreement (CCA), Audit Adoption, Self-Assessment Audit and
Onsite Audit through organization procedure
Collaborates with cross-functional and suppliers' teams to address top quality issues.
Own identified supplier driven non-conformances and manage the timely closure of NC's within
Trackwise.
Own or support identified supplier CAPAs and manage to timely root cause investigation,
implementation and closure.
Communicate & collaborate with suppliers regarding non-conformances, escalating supplier
corrective action requests as required.
Participates and may lead in the creation and/or review of new or modified procedures.
Maintain KPIs for monitoring of supplier quality processes, perform analysis, and interpret trends,
identifying and activating on appropriate actions as necessary.
Applies statistical methods of analysis and process control to external operations.
Support manufacturing transfers to/from other plants/facilities, executing appropriate quality
activities.
Lead quality issues with suppliers & partner with Internal Customers; Lead effective supplier
containment and corrections/corrective actions
Act as point of contact for Internal/ External Customer groups on key compliance issues related to
assigned suppliers
Responsible for accuracy and integrity of supplier data that ensures compliance with documented
procedures & processes.
Ownership and reporting on all quality issues associated with the assigned suppliers. Ensure all
assigned supplier related material quality issues are effectively communicated to key stakeholders.
Maintain structured communication channels with strategic sourcing, identifying responsibility by
commodity / supplier.
Deliver continuous improvement activities focusing on supplier quality.
Participate in supplier audit program - planning, execution and closure.
Partner with SQM functions and Strategic Sourcing on the developments and approval quality
assurance agreements with suppliers.
Ability to collaborate effectively with lead cross functional team
Qualification:
Bachelor's Degree in Engineering or Science-related field
5+ years' experience in quality, engineering, manufacturing, or highly regulated environment
Fluent in written, oral in English and
Understanding of US and International Medical Device Regulations.
Strong knowledge of Quality Concepts (e.g. Risk Management, NC/CAPA, Audits, Statistics).
Must possess strong communication, project management and influencing skills as well as have
the ability to manage multiple tasks simultaneously.
Strong interpersonal skills, written, oral communication and negotiations skills.
Strong in critical thinking and "outside the box" thinking.
Highly developed problem-solving skills. Strong analytical skills.
Demonstrated ability to work independently and as part of cross-functional teams
French
Knowledge of application of Regulatory requirement including ISO 13485, FDA and International
requirements
Enhanced quality system requirements (QSR) throughout business unit by improving quality
process and CAPA Closure
Implementing SICR- Supplier Initiated Change Requests (DCR, ECR, MCR) through Change
management Process and as per ISO 13485 & CFR 21 Part 820 requirements
Presenting Supplier Initiated Change Requests to Change Management Board (CMB) for review &
Approval
Review and Closure of Supplier Audit Non-Conformities as per NC & CAPA management System
(Track wise)
Review of Supplier deliverables like MSA, SPC, GD&T, Process Validation, PPAP, FMEA etc.
Conducting Supplier's Pre-Assessment Audits with Sourcing & RAQA Leads.
Implementing Change Control Agreement (CCA), Audit Adoption, Self-Assessment Audit and
Onsite Audit through organization procedure
Collaborates with cross-functional and suppliers' teams to address top quality issues.
Own identified supplier driven non-conformances and manage the timely closure of NC's within
Trackwise.
Own or support identified supplier CAPAs and manage to timely root cause investigation,
implementation and closure.
Communicate & collaborate with suppliers regarding non-conformances, escalating supplier
corrective action requests as required.
Participates and may lead in the creation and/or review of new or modified procedures.
Maintain KPIs for monitoring of supplier quality processes, perform analysis, and interpret trends,
identifying and activating on appropriate actions as necessary.
Applies statistical methods of analysis and process control to external operations.
Support manufacturing transfers to/from other plants/facilities, executing appropriate quality
activities.
Lead quality issues with suppliers & partner with Internal Customers; Lead effective supplier
containment and corrections/corrective actions
Act as point of contact for Internal/ External Customer groups on key compliance issues related to
assigned suppliers
Responsible for accuracy and integrity of supplier data that ensures compliance with documented
procedures & processes.
Ownership and reporting on all quality issues associated with the assigned suppliers. Ensure all
assigned supplier related material quality issues are effectively communicated to key stakeholders.
Maintain structured communication channels with strategic sourcing, identifying responsibility by
commodity / supplier.
Deliver continuous improvement activities focusing on supplier quality.
Participate in supplier audit program - planning, execution and closure.
Partner with SQM functions and Strategic Sourcing on the developments and approval quality
assurance agreements with suppliers.
Ability to collaborate effectively with lead cross functional team
Qualification:
Bachelor's Degree in Engineering or Science-related field
5+ years' experience in quality, engineering, manufacturing, or highly regulated environment
Fluent in written, oral in English and
Understanding of US and International Medical Device Regulations.
Strong knowledge of Quality Concepts (e.g. Risk Management, NC/CAPA, Audits, Statistics).
Must possess strong communication, project management and influencing skills as well as have
the ability to manage multiple tasks simultaneously.
Strong interpersonal skills, written, oral communication and negotiations skills.
Strong in critical thinking and "outside the box" thinking.
Highly developed problem-solving skills. Strong analytical skills.
Demonstrated ability to work independently and as part of cross-functional teams
French
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