1st shift Operator I (Monday-Friday 7:00 am-3:00 pm)

Solesis•Winston-Salem, NC

About The Position

The Operator performs assembly, operates manufacturing lines and equipment, prints labels, and packages components in accordance with applicable Work Instructions (WI), Visual Inspection Criteria, Standard Operating Procedures (SOP), and internal specifications in an FDA-regulated environment. The role has four levels defined by the Operator Career Ladder. Workstations are assigned based on successful completion of training, and the employee may focus on one area or functional task or be cross-trained in multiple areas. This is a first-shift position working Monday through Friday from 7:00 a.m. to 3:00 p.m. Operators follow production standards and rates while meeting quality requirements, completing required inspections and testing, documenting work, and operating equipment safely. The position may also involve inventory or cycle counts and extended hours when required.

Requirements

High school graduate or equivalent.
Ability to communicate effectively with coworkers and management.
Ability to understand and follow English-language SOPs, Work Instructions, policies, and procedures.
Basic mathematical skills, including addition, subtraction, multiplication, and division using whole numbers, common fractions, and decimals.
Basic computer skills, including the ability to use MS Outlook and automated manufacturing and quality systems.
Ability to complete required paperwork according to work instructions, standards, or other specifications.
Excellent dependability and reliability.
Ability to work well with others in a team environment.
Willingness to accept change, learn, and work with new processes.
Ability to work extended hours when required.
20/20 vision with corrective eyeglasses and ability to pass a color perception test.

Nice To Haves

Basic understanding of Good Manufacturing Practices (GMP) and experience working in FDA-regulated industries.
Familiarity with an ERP system and an electronic Quality Management System (eQMS).

Responsibilities

Follow Standard Operating Procedures and Work Instructions to manufacture and package medical-device components.
Perform assembly, machine operation, label printing, and packaging as required.
Work in multiple areas when cross-trained or focus on an assigned primary area.
Meet production standards and rates while adhering to quality requirements.
Conduct in-process inspections and testing to verify material meets criteria.
Escalate defects to management and document or report them in production records.
Measure products and perform simple mathematical calculations to verify specifications.
Label and package products according to internal specifications.
Perform leak testing and operate pouch-sealing equipment according to work instructions and company procedures.
Maintain clean machinery, parts, and the surrounding work area.
Complete paperwork associated with daily tasks according to applicable instructions and standards.
Operate equipment within safety guidelines and report nonconformance.
Perform inventory or cycle counts when required.