Position Overview

This position supports programs that reduce overall costs and improves 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. Assists 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. Job duties:
  • Performs supplier risk assessment and participates in supplier selection to evaluate quality systems, processes and services of suppliers.
  • Oversees supplier monitoring, Supplier Corrective Action Requests (SCARs) and supplier related Non-Conformance Reports (NCRs), purchased part assessments, and evaluates 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.
  • Executes (SCAR); reviews supplier quality performance and escalates based on risk, where needed.
  • Works with R&D, Operations and Procurement to ensure compliance for materials/components & services.
  • Supports regulatory compliance gaps at suppliers (e.g. supplier quality system and process development activities).
  • Supports supplier improvement programs, where needed.
  • Performs additional responsibilities as assigned.

    1. Bachelor’s degree in Engineering or a science discipline or equivalent.
    2. Three (3) years of total engineering 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. Experience with risk assessment files (dFMEA, sFMEA).
    6. Experience with engineering/or supplier change process.
    7. Experience with Root Cause Analysis, Corrective and Preventive Action methods.
    8. Experience with statistical techniques & process validations.
    9. Strong working knowledge of FDA and cGMP regulations and documentation practices, including SOP creation.
    Desired Qualifications
    1. Master’s degree is a plus.
    2. Good stakeholder management skills (Procurement, Q&R, R&D).
    3. Project management experience.
    4. Good written and verbal communication skills.