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).
- 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.
- 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