Position Overview

The Sr. Supplier Quality Engineer supports programs that reduce overall costs and improve supplier performance. Organizes and reports key supplier performance metrics to the Quality organization and other departments. Performs supplier audits to evaluate quality systems, process, services and supplier capabilities. Assist with Material Review Board (MRB) process to resolve issues with supplier related components and services. Drives supplier root cause analysis and corrective action process to prevent recurrence of quality issues. Typical job duties
  • Perform supplier risk assessment and participate in supplier selection to evaluate quality systems, processes and services of suppliers.
  • Oversee Supplier monitoring, Supplier Corrective Action Request (SCARs) and supplier related Non-Conformance Reports (NCRs), purchased part assessment, and evaluate impact of Supplier Change Requests.
  • Assists with management of approved suppliers, via the Approved Supplier List (ASL).
  • Participates in the MRB process; to drive supplier quality improvement, as required.
  • Execute (SCAR); Review supplier quality performance and escalate based on risk, where needed.
  • Work with R&D, Operations and Procurement to ensure compliance for materials/components & services.
  • Support regulatory compliance gaps at suppliers (e.g. supplier quality system and process development activities).
  • Support supplier improvement programs, where needed.
    1. Must have a bachelor’s degree in Engineering or a science discipline or equivalent experience.
    2. Must have six (6) or more years of total supplier quality experience in a medical device or a pharmaceuticals manufacturing environment.
    3. Working knowledge of appropriate global medical device regulations, requirements and standards such as ISO 9001, ISO13485, QSR, MDD.
    4. Expertise/experience in root cause analysis, corrective/preventive action methods and problem solving with quality tools such as: 6-sigma / 8-D / CAPA / FMEA, 5 WHYs etc.
    5. Audit experience in quality assurance activities for medical device and drug products.
    6. Experience with Root Cause Analysis, Corrective and Preventive Action methods.
    7. Experience with process validations.
    Desired Qualifications
    1. Good stakeholder management skills (Procurement, Q&R, R&D).
    2. Project management experience.
    3. Good written and oral communication skills.