Job Description Summary

Supplier QA Engineer will be responsible to ensure a timely and proper follow up on supplier quality issues reported in production areas. Provide technical support on any possible supplier quality issue happening in production areas.Ensure proper follow up and closure of all suppliers related NC's generated in the production and/or incoming areas. Ensure proper analysis and follow up all supplier related customer complaints. And ensure continuous updating and maintenance of the approved supplier list. Maintenance of the SMC reports.

Job Description

Key Responsibilities:

• Manage supplier quality issues reported in production and/or Incoming areas.
• Manage Supplier Corrective Actions.
• Follow up all supplier related customer complaints.
• Updating and maintenance of the approved supplier list as required.
• Review and maintenance of Supplier Quality Agreements
• Maintain communication with Regulatory to assure accurate identification of critical and crucial suppliers.
• Coordinate the completion of Supplier Surveys/Assessments.
• Work with Procurement/Sourcing during supplier selection to provide quality-related input for potential suppliers.
• Support supplier audits and improvement projects.
• Provide support / actively participate in internal and external audits (FDA, ISO, Corporate, and Internal)
• Work with Corporate project teams to coordinate and implement supplier quality initiatives in the plant.
• Provide guidance on documentation associated with supplier qualification and supplier-driven changes including supplier validations, supplier quality agreements, process controls, and compliance to regulations and industry standards.
• Periodically assess suppliers and Supplier Quality team practices to ensure global regulatory requirements are met.
• Collaboration with Projects team with PPAP process as required.

• Bachelor's degree in engineering or equivalent.
• 2 years of experience, medical device preferred.
• Strong understanding of Root Cause Analysis, Corrective Action, Preventive Action, Efficiency Verification.
• Strong working knowledge of statistical quality tools and statistical process control (SPC)
• Strong working knowledge of QSR, ISO13485 / ISO9001, MDD/MDR, Risk Management, and Canadian Medical Device requirements preferred.
• Able to manage several projects at the time.
• Demonstrate effective communication, presentation and influencing skills, bilingual English and Spanish.