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Supplier Quality Engineer

Supplier Quality Engineer

Intellectt IncGainesville, FL, United States
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Position : Supplier Quality Engineer

Location : Gainesville, FL (Onsite)

Job Description & Key Responsibilities :

  • Ensure compliance with ISO 13485, FDA, CFR 21 Part 820 and international regulations.
  • Enhance QSR processes through CAPA closure and quality improvements.
  • Manage Supplier Initiated Change Requests (DCR, ECR, MCR) via Change Management; present to Change Management Board (CMB) for approval.
  • Review / close Supplier Audit Non-Conformities and CAPAs (Trackwise).
  • Review supplier deliverables : MSA, SPC, GD&T, Process Validation, PPAP, FMEA .
  • Conduct pre-assessment audits with Sourcing & RAQA leads; manage CCA, audit adoption, self-assessment, and onsite audits.
  • Lead supplier quality issue resolution : non-conformances, CAPAs, containment, corrective actions.
  • Collaborate with cross-functional and supplier teams; escalate supplier corrective actions when required.
  • Support manufacturing transfers, ensuring quality activities are executed.
  • Maintain KPIs, analyze supplier quality data, and apply statistical methods for process control.
  • Act as primary contact for compliance issues with assigned suppliers; ensure accuracy and integrity of supplier data.
  • Own and report all supplier-related quality issues, ensuring communication with stakeholders.
  • Partner with Strategic Sourcing / SQM to develop and approve quality assurance agreements.
  • Drive continuous improvement in supplier quality and participate in audit programs (planning, execution, closure).
  • Contribute to creation / review of procedures; collaborate effectively across teams.

Qualifications :

  • Bachelor’s Degree in Engineering or Science-related field.
  • 5+ years in quality, engineering, manufacturing, or regulated environment.
  • Strong knowledge of Risk Management, NC / CAPA, Audits, Statistics .
  • Understanding of US & International Medical Device Regulations .
  • Strong communication, negotiation, project management, and influencing skills.
  • Critical / analytical thinker with strong problem-solving skills.
  • Ability to work independently and within cross-functional teams.
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    Supplier Quality Engineer • Gainesville, FL, United States