Production Lead

**Job Summary:

**

Provide hands-on leadership for all safety room floor personnel in support of safety, compliance, productivity, quality standards and company policy. Monitor/adjust work of shift employees to schedule demands. Recommend improvements in production methods, equipment, operating procedures and working conditions and equipment. Responsible to uphold cleanliness standards.

**Essential Job Duties and Responsibilities:

**

• Support sustaining (Set-In-Order) standards for general work areas of the molding operation.

• Provide and maintain skill set necessary to properly operate, inspect and package product on the molding room floor.

• Drive expectations (Set-In-Order) “clean and tidy” standards, for all work areas.

• Set up Assembly, Packaging, and Test equipment, per validated processes, to produce medical devices or sub-assemblies. Work with Quality Technician for start-up approval of production lines.

• Monitor and provide ongoing feedback regarding the daily performance of shift employees and help to ensure product conformance to customer specifications and scheduled delivery dates, while helping to monitor the quality, production, scrap, safety, cost and customer service for the shift.

• Perform initial and refresher training for temporary and full-time employees to proper work methods per specifications and standard work instructions (SWI’s).

• Adhere to clean room processes and procedures.

• Regular attendance and professionalism.

• Set up, troubleshoot and assist in resolving process/equipment problems. Monitor processes, policies and procedures and recommend improvements in production methods, equipment, operating procedures, working conditions (safety, quality, productivity, and cost) and cost effectiveness.

• Work closely with customer service, quality, scheduling and various other departments to ensure production and quality of products meets specifications and delivery times.

• Post daily production, daily scrap, and monitor inventory of product used.

• Maintain lot traceability and perform line clearance and reconciliation, as required.

• Investigate and resolve production material variances.

• Perform Corrective and Preventative Action duties (CAPA), Continuous Improvement and 6S Lean activities as assigned.

• Where errors exist, revise/write standard work instructions for review, approval and submission to document control.

• Other duties as assigned.

**Essential Qualifications:

**

• Demonstrated abilities in prioritization, multi-tasking, problem solving while maintaining strong attention to detail and willingness to collaborate in a team environment.

• Excellent customer service skills, communication skills, comprehensive and troubleshooting skills are necessary.

• Able to skillfully navigate obstacles to generate positive outcomes.

• Strong interpersonal and communication skills; be a team player; and have the ability to develop a team atmosphere. Must be able to communicate with all levels of staff.

• Ability to understand and practice company and customer quality requirements.

• Knowledge and practical understanding of various assembly methods and secondary operations equipment. Knowledge of equipment setup, operating techniques, and troubleshooting.

• The ability to visualize and help design/develop tools, fixtures, processes to obtain maximum efficiency.

• Working knowledge of ISO, FDA, GMP, and OSHA standards.

• Technical background desirable.

• Competent in the use of computers, basic Microsoft Office Suite, bar code readers, with the ability to access and enter data as necessary.

• Ability to read, write and communicate in English.

• High School Diploma or equivalent required.

**ADA Requirements:

**

• Stand, walk, bend, squat, twist, reach or otherwise move frequently

• Occasional repetitive motion and grasping

• Occasional climbing to reach areas on machines or racks

• Lift, move or otherwise transfer up to 50 lbs. occasionally, >20 lbs. frequently

• Typically sits, grasps items or performs keyboarding for occasional operation of a computer

Exposure to typical machine shop physical hazards which may require respiratory protection

You should be proficient in:

• Standard Operating Procedures (SOPs)
• Supervisory Experience
• Production Optimization
• Production Planning & Scheduling
• Good Manufacturing Practices (GMP)
• Scheduling Experience

Machines & technologies you'll use:

• ERP Software