Quality Engineer

Supplier Quality Engineer Work Flexibility: Hybrid What you will do: Lead quality issues with suppliers with Internal business partners; 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. Participate in External Audits and Internal Audits as needed. Ensure Regulatory compliance in area of responsibility to GMP of all medical device’s regulatory agencies (i.e. FDA, IMB, Notified bodies, etc.) Management of SQA. 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. Liaising with the Manufacturing and Quality groups, in assessing and addressing material quality issues with assigned suppliers. Maintenance of the Approved Supplier List (ASL) in conjunction with the Mergers and Acquisitions, Global Sourcing, regulatory, Supplier controls and Audit functions. Deliver continuous improvement activities focusing on supplier quality. Participate as required in SCRB in conjunction with key stakeholders & support assessment of supplier changes. Participate in supplier audit program – planning, execution and closure. Participate in supplier reviews for assigned suppliers as required. Participate in cross functional projects both locally & globally as required. Partner with SQM functions and Strategic Sourcing on the developments and approval quality assurance agreements with suppliers. What you will need: Bachelor’s degree (Supply Chain Management, Engineering, Quality or equivalent). 2+ years in handling Quality management systems, Supplier audits, agreements etc. 2+ years in Supply Management or Sourcing or other relevant functions Working knowledge of ISO 13485. Ability to effectively communicate and present information to suppliers, team members, team leaders, and top management. Ability to build relationships across multiple functions and levels both internally and externally. Knowledge of continuous improvement methodologies & cost reduction methodologies. Knowledge of supplier metrics & measurement methodologies and supporting systems. PC Literate (Track-wise, Excel, SharePoint). Basic knowledge of project Management tools is desirable. Strong analytical skills required. Travel Percentage: 10% Experience Level Mid Level