Job Title: 2nd Shift Cleanroom Assembler
Job Description
This role focuses on assembling and packaging medical devices and single-use surgical products in a controlled cleanroom environment. You will work on a 2nd shift schedule, performing hands-on production tasks that require repetitive motion, attention to detail, and adherence to strict quality and regulatory standards. The position supports the production of critical healthcare products by following documented procedures, maintaining accurate records, and collaborating closely with production, quality, and other internal teams.
Responsibilities
- Insert products into tubes using consistent, repetitive motion and appropriate force while maintaining safety and quality standards.
- Apply glue to medical devices, such as respirators, following specified techniques and procedures.
- Count, cut, measure, fold, or otherwise modify raw materials according to instructions in the Device Master Record.
- 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 and promptly report issues or nonconformances to the Production Supervisor.
- Seal products in their final packaging configuration, ensuring correct machine settings and adherence to sealing procedures.
- Prepare packaged work in progress for sterilization and complete all associated documentation and control numbers as required by QS and GMP.
- Maintain proper inventory control procedures, including product staging, segregation, and rotation to ensure accurate stock management.
- Perform and document scheduled facility cleaning tasks in accordance with QS requirements.
- Understand and follow proper cleanroom etiquette at all times to maintain a controlled environment.
- Communicate and collaborate effectively with production, purchasing, quality, and leadership to achieve assigned goals and objectives.
- Support the objectives of the quality management system and recommend improvements to processes and procedures as needed.
- Provide constructive feedback and support continuous improvement initiatives within the department.
- Perform other related duties as assigned by the Production Supervisor to support overall production needs.
Essential Skills
- Ability to work 2nd shift, Monday through Friday from 3:00 PM to 11:30 PM, with flexibility to work overtime or Saturdays as needed.
- Capability to perform repetitive manual tasks that require consistent use of force, such as inserting products into tubes.
- Ability to lift up to 25 pounds safely and repeatedly during the shift.
- Strong attention to detail and motivation to maintain high-quality work in a regulated environment.
- Basic English skills sufficient to read work orders and communicate with auditors and supervisors.
- Comfort working in an environment where many tenured employees primarily speak Spanish.
- Ability to operate basic production equipment in a manufacturing or assembly setting.
- Good verbal and written communication skills to interact with team members and document work accurately.
- Understanding of or ability to learn QS and GMP requirements and apply them to daily tasks.
- Willingness to follow strict cleanroom protocols, including gowning, de-gowning, and adherence to hygiene and attire rules.
Additional Skills & Qualifications
- Preferred 1 year of experience in a cleanroom, medical assembly, or warehouse environment.
- Demonstrated team leadership capabilities, including the ability to support and motivate colleagues.
- Experience working in general production, packing, or medical device manufacturing is beneficial.
- Ability to identify improvements and modifications to departmental procedures and share suggestions with leadership.
- Comfort with rotating or floating between different departments as operational needs require.
Why Work Here?
This opportunity offers a clear path from contract to potential long-term employment, providing stability for individuals who demonstrate strong performance and reliability. You will have access to medical, dental, and vision benefits, supporting your overall well-being. The environment encourages teamwork, positive attitudes, and continuous improvement, allowing you to contribute ideas and see the impact of your work on essential healthcare products.
Work Environment
You will work in a cleanroom environment within a small team of approximately four employees in a new department. The role is on 2nd shift, Monday through Friday