Supplier Quality Engineer

Position: Supplier Quality Engineer

Location: Gainesville, FL (Onsite)

Job Type: Contract

Required Qualification:

• Must have Auditor certification & Medical domain candidate only.
• Bachelor s degree in engineering or a science-related field.
• 5+ years' experience in quality, engineering, manufacturing, or a highly regulated environment.
• Fluent in written, oral 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 negotiation skills.
• Strong in critical thinking and "outside the box" thinking.
• Highly developed problem-solving skills. Strong analytical skills.
• Demonstrated.

Job Description & Skill Requirement:

• Knowledge of the application of Regulatory requirements, including ISO 13485, FDA, and international requirements.
• Enhanced quality system requirements (QSR) throughout the business unit by improving the quality process and CAPA Closure.
• Implementing SICR- Supplier Initiated Change Requests (DCR, ECR, MCR) through the 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 the organization's 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 NCs within Track-wise.
• Own or support identified supplier CAPAs and manage 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 the 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 development and approval of quality assurance agreements with suppliers.
• Ability to collaborate effectively with a lead cross-functional team.