Responsible for meeting department cost, quality, delivery, and safety goals. Department objectives will be achieved by coordinating activities across work teams and efficiently allocating resources. Create and maintain metrics to achieve departmental goals. Monitors work to ensure quality, and continuously promotes Quality First Time
- Balance workload across teams; monitors total overtime spending.
- Approve time keeping records and resolve any time and attendance issues.
- Responsible for hiring new employees.
- Responsible for performance review process and associated merit increases.
- Responsible for cost center spending and approval of expenses as authorized; provide input to departmental budgets.
- Responsible for performance issues and disciplinary actions.
- Identify areas for improvement, propose changes, gain approval and implement process change.
- Interface with other functional groups to gain alignment in the implementation of new processes and resolving problems.
- Resolve any technical issues as required.
- Ensure team’s compliance with quality system requirements.
- Department: Instrument Maintenance
Additional Essential Functions:
-Ensures the timely completion of preventive maintenance, instrument service and/or calibrations for manufacturing area.
-Provides technical support for daily production issues related to manufacturing equipment. Resolves technical and/or compliance issues.
-Responsible for Lean manufacturing initiatives. Monitors existing processes and equipment for continuous improvement opportunities. Identifies, leads, and implements process/equipment improvements in a timely manner.
Additional Minimum Qualifications:
-Degree in relevant engineering discipline, or other related technical field preferred.
-Relevant experience - Medical Device manufacturing, supporting automated manufacturing equipment/technologies, Lean Systems
-Understanding and strong working knowledge of FDA Quality System regulations, Bio-safety and Occupational Hazardous Environments.
Associate's Degree with 8 years relevant experience
Bachelor's Degree with 5 years relevant experience
Master's Degree with 3 years relevant experience
Experience must include 2 years of supervisory, process, or project management
QSR, MDI/Lean MFG training, relevant experience in materials environment and has functioned as a Buyer, ERP/MRP system knowledge, knowledge of International shipment regulations and requirements, and hazardous material transportation guidelines.
Preferred: Oracle and SAP Experience