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
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