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Manufacturing Manager, Cleveland, OH

Unique opportunity to grow and create a new functional area focusing on influencing manufacturing systems (processes) and operations and supporting the Quality Management System (QMS).

Primary Responsibilities

  • Drive process improvements for Manufacturing Operations to resolve issues.
  • Ensure Quality compliance while supporting timely release of product to meet forecast.
  • Work towards resolution of manufacturing issues (NCMR and CAPA support).
  • Establish and maintain Manufacturing Operations QMS documents (SOP,WI, etc.)
  • Review and approve component suppliers and contract manufacturing partners in accordance with supplier monitoring procedures.
  • Represent Operations on Engineering team and development projects.
  • Evaluate device costs.
  • Assist with day to day operations including vendor identification, quoting, purchasing, receiving, inventory management, and supplier management.

Requirements

  • Bachelor’s Degree in Engineering or related field.
  • Minimum 5-8 years of experience with FDA/GMP regulated medical device manufacturing.
  • Project management including planning, execution, and meeting time and budget constraints.
  • Understanding of medical device DHF, DMR, and DHR files management and documentation requirements.

Why Join Our Team?

  • Entrepreneurial work environment
  • Small, collaborative office environment
  • Competitive compensation and benefits
  • Employee Wellness Program
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