Medical Device Packaging Lead

PURPOSE  

A Medical Device Packaging Lead is a motivated self-starter who effectively follows PMC’s operator instructions to assemble and package products on time while ensuring specifications are met and maintaining the production environment.  The associate will complete visual inspections, and other testing as required, to identify non-conformities in parallel with production. 

A successful Medical Device Packaging Lead must be capable of working with minimal supervision, have a “can do” attitude, possess creative problem-solving skills and be willing to do “whatever it takes” to complete assigned tasks efficiently and effectively.  This team member should have excellent interpersonal skills, great attention to detail and be highly organized with the ability to multi task with minimum interruption to work progress. 

RESPONSIBILITY 

• Responsible for packing of medical devices according to PMC’s Standard Operating Procedures (SOP) 
• Responsible for following all established policies, practices and procedures related to all job duties 
• Responsible for following all Good Documentation Practices (GDP), Good Manufacturing Practices (GMP) and PMC policies 
• Prepare work area and keep it safe, clean and organized per PMC standards 
• Verify accuracy of product produced against specification and resolve discrepancies as directed by PMC standards 
• Use manufacturing and quality assurance specifications to determine acceptance on all packaging 
• Train, coach, and mentor team members to ensure proficiency in packing. 
• Packaging and Labeling - Set up and operate the packaging operation with minimum down time and interventions. Perform all cleaning, line clearance, staging, set-up and batch reconciliation activities to support the packaging operations. 
• Participate in the review of Operator Instructions 
• Inspecting labels for quality to the customer’s expectations. 
• Perform additional duties as necessary that contribute to the overall efficiency of the company. 

CORE COMPETENCIES 

• Exhibits objectivity and openness to others’ views. Takes personal accountability for contributions to the team and organizational results. 
• Demonstrated accuracy and thoroughness; looks for ways to improve and promote quality. Consistently checks all documents for errors and constantly strives for right the first time mentality.
• Demonstrates the appropriate technical knowledge necessary to make sound decisions on development issues with minimal supervision. 
• Demonstrate the ability to portray the appropriate level of integrity and professionalism. 
• Demonstrate the ability to complete tasks accurately and according to established and shifting timelines. 
• Energetic, execution-focused, self-motivated, and organized individual who is accustomed to working in a deadline-focused, high-pressure environment. 
• Results-oriented and efficient. 
• Professional attitude and detail orientation. Ability to troubleshoot minor to immediate issues. 
• Takes initiative to identify issues, troubleshoot, propose solutions, and keep management informed. 

EDUCATION, EXPERIENCE AND SPECIAL SKILLS: 

• High school diploma or equivalent; additional education or training in manufacturing or logistics is a plus. 
• Strong leadership skills with the ability to motivate and inspire team members to achieve production goals. 
• Excellent organizational and time management abilities, with a focus on prioritizing tasks and meeting deadlines. 
• Attention to detail and commitment to maintaining high standards of quality and accuracy. 
• Effective communication skills, both verbal and written, for interacting with team members and other departments. 
• Must be able to work in a manufacturing work cell and cleanroom environment 
• Must be able to perform repetitive work for extended periods of time 
• Extended hours, including weekends may be required to support the organizations objectives 
• Must have excellent documentation and organizational skills. 
• Experience with sterile barrier packaging is a plus. 
• Experience working in a clean room is a plus. 
• Experience with single use disposable medical devices is a plus. 
• Experience with seal integrity and seal strength testing is a plus. 
• Must maintain an acceptable level of performance and attendance.  Team Member will be placed on a Performance Improvement Plan if they reach 4 points under the Attendance Policy and/or reach a Written level under the Corrective Action steps.  

QUALIFICATIONS: 

• Maintain OEE above 95% 
• Maintains Scrap rates below standard 
• Quality standards maintained 
• Maintains organized workspace