ShiraTronics Inc.

Key Requirements:

  • BS in an Engineering or Life Sciences discipline.
  • 3+ years Supplier Quality Engineering experience.
  • Knowledge of ISO 13485:2016 and 21 CFR Part 820.
  • ISO 13485:2016 Lead Auditor Certification and/or ASQ Certified Quality Engineer (CQE).

Key Responsibilities:

  • Review engineering and manufacturing specifications to identify materials needed for product assembly for all manufactured goods
  • Researching, sourcing, and assessing the best vendors to supply the necessary materials.
  • Contact vendors and liaise between product engineers and suppliers to negotiate contracts to secure required materials for the production floor
  • Conduct supplier quality control audits to ensure vendors and their supplies remain in compliance with company and federal manufacturing and production standards
  • Communicate with vendors regularly to address any concerns and foster an environment that facilitates continual improvement in working relationships
  • Maintain a supplier database and include performance evaluations and quality control audits in the database for in-house access by company and manufacturing management personnel
  • Developing inspection procedures to ensure product conforms to specifications.
  • Coordinating Receiving Inspection, Non-Conforming Material Reporting (NCMR) and Product Disposition activities.
  • Assisting with execution of the ShiraTronics Corrective and Preventive (CAPA) process.
  • Providing Quality review of proposed documentation and/or product changes.
  • Reviewing our manufacturing specifications to identify materials needed for production.
  • Researching, sourcing, and assessing the best vendors to supply the necessary materials.