Applies skill and dexterity in the preparation of raw materials, work-in-process (WIPs), semi-finished and finished goods for the manufacturing process, in keeping with regulatory and company guidelines.
Key Responsibilities:
• Operate a variety of manufacturing equipment, which may include , ultrasonic cleaners, tissue deflectors, or others, in the manufacturing process of medical devices - including assuring appropriate settings and parameters
• Select and utilize the associated equipment manufacturing fixtures/aids, such as jigs, cutting dies, templates, or any other required fixture associated with assigned operation/task
• Review, follow and perform job functions in compliance with established work instructions and adherence with SOPs, including recording traceable information on device history records, which may include entry into JDE and any other systems, including issuing materials, terminate work orders, as required
• Perform component transfers as required, maintain integrity of JDE and MES system at all times.
• Perform fixtures sanitization per procedure.
• Unload tools/components/manufacturing aids from ovens/autoclaves.
• Maintain accurate inventory in JDE and MES and ensure the quantity tallies with physical count.
• Other incidental duties: General work area housekeeping, general sanitization of work area with approved chemicals, material handling, printing
Education and Experience:
Secondary Education with previous GMP, clean room, medical device experience Preferred
No previous related experience Required
Additional Skills:
• Ability to use a variety of manufacturing equipment, hand eye coordination, and high manual dexterity
• Basic understanding of manufacturing procedures
• Successful completion of ongoing job training of manufacturing process steps
• Ability to read, comprehend, and speak English, and good communication skills, required
• Basic computer skills (tablet/Surface Pro), preferred
• Ability to effectively provide and accept feedback from colleagues based on performance
• Must be able to work in a team environment, primarily with departmental colleagues and supervisor, and with minimum supervision by following detailed established operating instructions
• Strict attention to detail
• Trouble shooting abilities and systems understanding to investigate and resolve inventory discrepancies
• Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control
