QUALIFICATIONS

Required:

• Position requires High School diploma or GED
• Ability to read and write in English
• Minimum five (5) years of production experience in a manufacturing clean room environment is required
• Minimum two (2) year of large (10+) team production leadership in a high-speed manufacturing environment is required

Preferred:

• Prior experience in a leadership role in an FDA regulated environment
• BS degree in Business or Engineering

Skills & Competencies:

• Demonstrated track record of positive leadership and proven ability to train and develop hourly employees on a manufacturing floor
• Able to consistently handle multiple tasks and priorities in a constantly evolving environment while always demonstrating the highest levels of professional maturity and calm when under pressure
• A self-starter who is able to work with little to no supervision and does not need to be given day to day direction to prioritize the team’s work
• Highly detailed oriented and able to detect all abnormal issues with product, paperwork and equipment
• Experienced and confident in working with and troubleshooting high speed automation and advanced robotics
• Exceptional communication and interpersonal skills when interacting with direct reports, other shifts, department management and all other employees
• General computer skills required on a manufacturing floor such as ability to use Microsoft Office Suite along with ERP and time management systems among others

Physical Requirements:

• Must be able to remain in a stationary position throughout the workday
• Must have fine manual motor control and dexterity when working with small parts
• Must be able to see and identify very small product defects with both magnification and the naked eye as needed
• Must be able to wear PPE including lab coats, surgical masks, hairnets, beard covers, lab coats, safety glasses and nitrile gloves for up to the entire workday excluding breaks and lunch
• Must be able to move up to 25 pounds, as needed

RESPONSIBILITIES:

• Responsible for the real time review of daily production paperwork, completion of daily SAP transactions, immediate identification of all procedural deviations and the creation/completion of product non-conformity reports and CAPAs as needed
• Responsible for planning and maintaining schedules, directing the work of employees, training requirements, providing direction, coaching, counseling and leadership to improve performance and enhance service quality
• Ensure the production of medical devices in full compliance with Enable Injections Standard Operating Procedures, Good Manufacturing Practices and FDA regulations
• Ensure all production documentation is complete and accurate daily through exceptional attention to detail
• Escalates to Manufacturing Manager operational detail and planning risk as required to comply with production planning and to support organizational initiatives
• Ensure that the cleanroom and all equipment are operated, maintained and cleaned in full compliance with governing procedures daily
• Lead the hiring, training and scheduling of all manufacturing assembly technicians
• Complete employee performance reviews for all manufacturing assembly technicians and provide ongoing feedback on a consistent basis with each employee
• Monitor equipment performance and product scrap and escalate all abnormal issues
• Ensure proper documentation and reporting of all equipment repairs, modifications, adjustments and preventative maintenance activities and that all equipment is in a state complaint with applicable procedural requirements prior to use
• Manage the requisition and consumption of raw materials and the receipt of finished goods to inventory while accurately accounting for all scrap and labor within SAP
• Initiate, lead and author SOP Document Changes within Enable Injections controlled document management system
• Actively identify and champion process improvements in the manufacturing area
• Accurately manage employee time and attendance and hold employees accountable to company expectations for employee attendance and punctuality
• Provide prompt support to all other departments in the completion of administrative and all other issues as needed
• Ensure timely and accurate communication between other shifts and all other departments