Position Overview

The Lead of Supplier Quality Engineering (Lead of SQE) is responsible for the receiving inspection, quality release and supplier quality areas. The primary responsibilities include the coordination and verification of suppliers according to quality standards and company requirements, oversee the coordination of and perform supplier audits to ensure compliance with regulatory standards, as well as actively participating in strategic development based on quality control plans. Additionally, resolve component quality issues identified during the receiving inspection, manufacturing and supplier evaluation processes. Manage the receiving inspection and release areas ensuring the release of raw material to production areas based on company requirements and ensure the release of finish product based on supply chain requirements. Job duties:
  • Performs analysis and identifies trends in the inspection of finished products, in-process materials, raw materials, and recommends corrective actions when necessary.
  • Handles problem solving and root cause analysis activities with suppliers and customers to eliminate recurrence of defects.
  • Utilizes process improvement tools to drive process and product quality.
  • Monitors supplier quality levels and performs development activities with strategic suppliers to ensure quality performance goals are met.
  • Performs supplier re-evaluations based on company requirements.
  • Initiates action at the receiving inspection lab or manufacturing lines to prevent the occurrence of any non‐conformities relating to product, process, and quality systems.
  • Maintains approved supplier list updates based on company requirements.
  • Performs supplier quality audits.
  • Develops projects to improve receiving inspection and release capabilities.
  • Develops and executes test method validations for receiving inspections and release inspections.
  • Develops and executes software and equipment validations.
  • Supplier process qualification - ensures supplier adherence to work instructions, process control plans, engineering drawings and specifications.
  • Works closely with suppliers and R&D, Supply Chain and Quality Engineering groups to ensure potential suppliers (second sourcing) for development projects meet requirements for qualification.
  • Generates a monthly supplier performance report including input from NCRs, SCARs and supplier ratings.
  • Assigns and prioritizes work assignments with Supplier Quality Engineers and receiving inspection/release Supervisors.
  • Provides training, improves technical skills, and provides career development for associates.
  • Maintains accessible records for internal and third-party audits.
  • Manages the supplier corrective action request process.
  • Manages the quality actions reports or CAPA's assigned to the area.
  • Performs additional duties as assigned.
    1. Bachelor’s Degree in related field or equivalent.
    2. Minimum of six (6) years of related supplier quality experience.
    3. Medical device industry experience.
    4. Good written and verbal communication skills.
    5. 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.
    6. Working knowledge of appropriate global medical device regulations, requirements and standards such as ISO 9001, ISO13485, QSR is required.
    7. Lead Auditor of ISO13485 or equivalent.
    8. Experience managing engineering staff.
    9. Ability to manage multiple projects and priories concurrently.
    10. Good computer skills including MS Word & Excel.
    11. Ability to travel approximately 25 – 50%.
    Desired Qualifications
    1. Solid understanding of receiving inspection and finish product release processes including statistical sampling, component measurement techniques, specifications, sterilization and drawings.
    2. Excellent problem analysis and resolution skills.
    3. Ability to collaborate within a team as well as work independently.
    4. Quality Certification (Ex: CQE, SSBB, SSGB, CQM)
    5. Advanced degree preferred.