Essential Duties and Responsibilities:
- Ensures effective employee relations and provides employee coaching and development.
- Provides leadership for quality, productivity, safety, and morale to achieve positive results and a productive work environment.
- Works to continuously improve processes and increase employee skills per training requirements.
- Completes annual performance evaluations in a timely manner and ensures compliance with company policies and procedures.
- Manages employee work schedules and overtime. Ensures department compliance with company policies.
- Manages decontamination, inventory, investigation, repair, and disposition of returned devices as required per procedures and policy.
- Manages department inventory activity to maintain operational levels and support business and organizational goals.
- Ensures documentation supporting service and complaint processes is timely and meets requirements.
- Create device history records for repair devices.
- Responsible for ensuring preventative maintenance is performed on equipment as required.
- Act as liaison between cross functional departments to maintain up to date knowledge of business trends and policy and adjust department according to new business developments.
- Creates and manages department metrics, analyzes data and identifies trends for further review by appropriate departments and management.
- Works with project teams to provide timely support to ensure projects are successful.
- Ability to travel up to 5%
Education and Experience:
- High school diploma or equivalent required. Bachelor's degree preferred.
- 3 years of experience in a production/manufacturing environment required.
- Experience servicing medical devices or similar products preferred.
Knowledge and Skill Requirements/Specialized Courses and/or Training:
Knowledge of FDA Quality System Requirements, ISO 13485 Quality System Requirements, ISO 14971 Risk Management Requirements and Good Manufacturing Practices. Familiar with Bio-hazardous material handling, storage, and disposal.
Machine, Tools, and/or Equipment Skills:
Various light duty machines and hand tools. Project management system skills required, preferably Playbook, MS Project, or Workfront. Advance Microsoft Excel skills and Intermediate Microsoft Word and PowerPoint required. Must have working experience with ERP systems, preferably SAP.