1st Shift Line Leader I (Monday-Friday 7:00 am-3:00 pm)

Solesis•Winston-Salem, NC

About The Position

The Line Leader operates and monitors production on a designated line and ensures the production folder is complete. The position has three levels, defined by the Line Leader Career Ladder. The role supports production of medical-device components and requires coordination with team members to meet production, quality, and safety requirements. The position is on 1st shift, Monday through Friday, from 7:00 am to 3:00 pm. Charter Medical is part of the Solesis family of companies and specializes in single-use solutions for the life sciences industry. Its North Carolina operations employ more than 150 team members across two facilities in Winston-Salem.

Requirements

High school graduate or equivalent.
Ability to communicate effectively with coworkers and management; business communications are conducted in English.
Ability to comprehend and follow SOPs, work instructions, and safety, quality, and HR policies and procedures written in English.
Basic mathematical skills, including adding, subtracting, multiplying, and dividing whole numbers, common fractions, and decimals.
Basic computer skills, including use of MS Outlook and automated manufacturing and quality systems.
Excellent interpersonal skills and ability to work well with others in a team environment.
Ability to complete paperwork according to work instructions, standards, and other specifications.
Dependability and reliability.
Meticulous attention to detail.
Willingness to accept change, learn, and work with new processes.
Must be able to work extended hours when required.
20/20 vision with corrective eyeglasses and ability to pass a color perception test.

Nice To Haves

Minimum 2 years of manufacturing experience preferred.
Minimum 1 year of previous leadership experience preferred.
Basic understanding of GMP and experience working within FDA-regulated industries preferred.
Familiarity with an ERP system and an electronic Quality Management System (eQMS) preferred.

Responsibilities

Retrieve, stage, and verify raw materials for the production line; complete associated paperwork, set up the line, gather materials, and establish team rotations.
Read and interpret the production schedule and direct the team to fulfill orders.
Review and close out the manufacturing portion of production folders, correcting or noting discrepancies.
Accurately report raw materials consumed on the production line in the ERP system.
Document non-conforming product details in the device history record.
Stop non-conforming materials and place them on hold, coordinating with quality and production supervision on proper storage as required.
Report downtime and waste.
Calculate and meet hourly production rates.
Elevate issues to the appropriate Manager, Supervisor, or Group Lead.
Perform cycle counts and assist with annual inventory.
Train operators on assigned lines and document their proficiency.
Demonstrate leadership capabilities.
Assemble and package medical-device components according to specifications.
Perform in-process inspection and testing; elevate and document defects in production records, using measurements and basic calculations to verify specifications.
Participate in cross-training and work at various stations to meet business needs.
Operate equipment to produce medical-device products, following safety guidelines.
Maintain clean machinery, parts, and surrounding areas.
Complete associated paperwork and ERP tasks, coordinating with the team to maintain quality requirements.