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Supplier Quality Engineer

Supplier Quality Engineer

Katalyst Healthcares and Life SciencesGainesville, FL, United States
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Responsibilities :

  • 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 Company within Track wise.
  • 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.
  • pplies 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.
  • ct 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.
  • bility to collaborate effectively with lead cross functional team.

Requirements :

  • 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 could 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.
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    Supplier Quality Engineer • Gainesville, FL, United States

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