Major Duties and Responsibilities:
- Plan, organize and direct staff to produce the required quality and quantity of products on all shifts
- Work with the schedule and prioritize jobs to adhere to due dates
- Maintain a clean, organized, uncluttered work area
- Provide work direction to production team members (Operators, Quality Inspectors, Technicians, etc.) and hold accountable for performance
- Assure all personnel are properly trained for tasks assigned and training documentation is completed and maintained
- Perform all IQMS functions related to production and have a thorough understanding of the transactions. (Material flow, tracking, and movement, scanning, reports, data accuracy, reporting, monitoring, recognizing incorrect data, etc.…).
- Maintain production system error free (IQMS and documentation)
- Use Data to analyze and solve problems in the areas of production issues and material issues
- Communicate and coordinate with all shifts and departments for smooth work transfer
- Responsible for production performance and meeting established key performance indicators
- Responsible for operating within established budget
- Initiate improvement projects that are in-line with company objectives and document progress
- Provide regular performance feedback and relevant communication to staff
- Ensure ISO, FDA, and GMPs are followed
- Work with Engineering to establish standardized processes with current and new jobs
- Ability to perform quality checks when needed
- Perform any other related duties as requested to ensure mini-company meets deadlines (load hoppers, schedule Operators, etc.)
Organizational Relationships:
- Directly reports to the Production Manager-Molding. Will work with all other departments and will have some customer interaction.
Experience and/or Educational Requirements:
- College degree and/or industry certifications or equivalent experience
- Excellent written and verbal communication skills
- Able to work well with people (team player) and processes
- Highly organized and detail-oriented
- May require flexible hours from time to time (possible overtime and weekends) to assure production schedules are met and off shifts are properly supported
- Good understanding of ISO, FDA, OSHA/MIOSHA regulations and GMPs
- Good understanding of ERP systems, preferably IQMS
- Good working knowledge of Microsoft Office
- Must have strong analytical skills
- Medical manufacturing experience a plus
Physical Requirements:
- Must be able to work and perform what would be considered standard practices for this type of position in the industry.