This position is an integral part of the Hardware Manufacturing Team and will report to the Senior Manager of Production Operations. It is located in Chaska, MN. If you thrive in a multifunctional, leadership role and want to work to build a best-in-class manufacturing organization—read on!
In this role, you will have the opportunity to:
- Assure compliance with FDA Quality System Regulations (QSR), Good Manufacturing Practices (GMP), and ISO regulatory requirements
- Work directly and in coordination with cross-functional team members to tackle problems and implement lean manufacturing improvement ideas
- Identify and recommend quality improvements including but not limited to production methods, equipment performance, product quality, and efficiencies
- Approve design changes/assessment of manufacturability for new processes, and management of resources (both monetary and labor-related)
- Train new team members on equipment operations and work procedures as needed
- Complete appropriate paperwork, maintain accurate records of production, and report status of work
- Maintain organization and strategic training plan for the work area
- High School degree with 8+ years’ experience, or bachelor’s degree with 5+ years’ experience, or master’s degree with 3+ years’ experience.
- Experience in a regulated industry preferred (e.g., FDA, ISO).
- Proficiency with Microsoft applications, including Word, PowerPoint, and Excel and the basic Windows operating system