Supplier Quality Engineer

Join to apply for the Supplier Quality Engineer role at Katalyst CRO

Overview

Responsibilities and qualifications described below for the role of Supplier Quality Engineer. This position involves collaborating with cross?functional and supplier teams to ensure quality and regulatory compliance across supplier activities.

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.
• 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.
• 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.

Requirements

Seniority level

Employment type

Job function

Industries

#J-18808-Ljbffr