Operator, II

OVERALL RESPONSIBILITIES:  

• Processes and packages various medical devices and biomaterials product in a controlled environment room  

POSITION DUTIES & RESPONSIBILITIES:  

• Performs duties and responsibilities as required per work instructions, training guides and S.O.P. guidelines  

• Set-up and operate various production equipment used to grind, weigh, measure, dry, mold, ultrasonic, assemble, laser etch and sterile package biomaterials and other medical devices 

• Requires a high level of concentration and attention to detail to ensure that products are properly labeled and packaged 

• Performs testing and gowning duties and responsibilities required per process sheets, work instructions and training guides 

•  Follow all procedures in a controlled environment  

• Perform equipment set up and PM’s when necessary  

• Keeps accurate and up-to-date batch records and data sheets on batches in-process 

•  Calibrate balances and weigh raw materials  

• Complete Quality Records as they relate to the manufacturing process 

• Performs SAP transactions and enters required computer data for each packaged product  

• Prints LMD, LPPF and BOM and all required packaging labels and performs label reconciliation 

• Maintains manufacturing areas in accordance with operating procedures and Lean philosophy 

• Strives to maintain product quality at all times while working towards continuous improvements 

• Know and follow all laws and policies that apply to one's job, and maintain the highest levels of professionalism, ethics and compliance at all times  

• Diligently participate in our compliance program-related activities as denoted by your supervisor or our Chief Compliance Officer  

• Works in other production areas as needed  

• Performs other related duties, as required  

EDUCATION & EXPERIENCE REQUIREMENTS:  

• High School Diploma (minimum) 

•  Clean room lab technician experience required. (Measuring of powders and liquids) 

• Medical device packaging a plus.  

• Computer experience with Windows, Manuscript, JDE and Label Software a plus  

• Has the ability to recognize equipment and product problems, and perform basic troubleshooting  

• Ability to work as a team and multitask in a controlled environment room to meet production schedule  

•  Demonstrated experience in compliance, quality, and productivity.