2nd Shift Cleanroom Assembly Prep

Job Description Job Title: 2nd Shift Cleanroom Assembly Prep Job Description This role supports the production of surgical single-use items, instruments, and kits by performing cleanroom assembly and preparation tasks on a 2nd shift production line. You will work with raw materials, perform precise assembly and packaging operations, and follow strict quality and documentation standards in a controlled cleanroom environment. This is a contract-to-hire opportunity with consistent weekday hours and potential overtime. Responsibilities Count, cut, measure, fold, and modify raw materials according to instructions in the Device Master Record, ensuring accuracy and completeness. Complete required inspections and documentation of quantities, control numbers, and other information in accordance with QS and GMP policies. Perform on-line inspection of each device as it is produced, promptly identify defects or issues, and report problems to the Production Supervisor for disposition. Seal products in their final packaging configuration, following established procedures and using correct machine settings for the sealer. Prepare packaged work-in-progress for sterilization and complete all associated documentation and control numbers per QS and GMP requirements. Maintain proper inventory control procedures, including product staging, segregation, and rotation to ensure accurate tracking and flow of materials. Perform and document scheduled facility cleaning activities in accordance with QS requirements. Understand and adhere to proper cleanroom etiquette at all times, including gowning procedures and contamination control practices. Operate basic production equipment safely and efficiently as part of the assembly and packaging process. Communicate and collaborate effectively with production, purchasing, quality, and senior leadership to accomplish assigned goals and objectives. Support and help meet the objectives of the quality management system and recommend improvements when opportunities are identified. Work as part of a small cleanroom team to meet daily production targets and maintain high quality standards. Provide positive, supportive teamwork that contributes to a constructive work atmosphere and strong morale. Identify and suggest improvements or modifications to departmental procedures to enhance efficiency, quality, or safety. Perform other related duties as assigned by the Production Supervisor. Follow established shift schedules, including 2nd shift hours and any required overtime on weekdays or Saturdays. Essential Skills Ability to lift up to 25 lbs safely and repeatedly during the shift. Strong attention to detail and motivation to maintain high quality and productivity. Preferred 1 year of experience in a cleanroom, medical assembly, or warehouse environment. Ability to operate basic production equipment in a manufacturing or assembly setting. Good verbal and written communication skills, including basic English to read work orders and communicate with supervisors and auditors. Capability to follow detailed work instructions, Device Master Records, and quality system procedures. Comfort working in a production, packing, and assembly environment involving medical devices and components. Ability to work effectively as part of a team to achieve shared production and quality goals. Willingness to work 2nd shift (approximately 3:00 PM – 11:30 PM, Monday through Friday) with overtime as needed on weekdays or Saturdays. Additional Skills & Qualifications Experience in cleanroom operations, medical device assembly, or medical product manufacturing. Familiarity with QS (Quality System) and GMP (Good Manufacturing Practice) requirements. Experience with general production, packing, and cleanroom procedures. Exposure to medical device components such as catheters and related assemblies. Comfort using hand tools, power tools, microscopes, and following blueprints or work instructions. Demonstrated team leadership capabilities and the ability to contribute to a positive team culture. Ability to identify improvements and modifications to departmental procedures and communicate them constructively. Comfort working in an environment where many tenured employees primarily communicate in Spanish, while using basic English for documentation and communication with supervisors and auditors. Why Work Here? You will join a growing organization that plays a direct role in supporting healthcare through the production of high-quality surgical products. The position offers a clear contract-to-hire path, #J-18808-Ljbffr Aerotek