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.

• 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.

• 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.

• 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.

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,