Supplier Quality Engineer

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 :