Quality Control 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