Performs sterile packaging and prepares packaging and labeling for finished products, in keeping with regulatory and company guidelines.
Key Responsibilities:
• Perform line clearance, including verifying all valve serial numbers are as listed on the work order being executed, labeling and packaging per valve model requirements of commercial, clinical, and product returns, registering each valve serial number into Wave Mark (inventory control system), per each work order processed and in strict keeping with quality, regulatory, SOP and work order standards.
• Review, follow and perform job functions in compliance with established work instructions and adherence with SOPs, including issuing components in JDE, recording traceable information on device history records, and signing off on work orders.
• Other incidental duties: General work area housekeeping
Education and Experience:
Secondary Education with previous GMP, clean room, medical device experience Preferred
No previous related experience Required
Additional Skills:
• Basic level of understanding of manufacturing procedures
• Basic computer skills with ability to process JDE transactions
• Ability to perform sterilize packaging and preparation of sterile components
• Ability to perform Sanitization Processor responsibilities
• Proven ability to complete, retain, and incorporate training coursework in the performance of new and advanced work procedures
• Able to read, comprehend and speak English, and good communication skills
• Must be able to work with minimum supervision by following detailed manufacturing instructions
• Work in a Team environment, primarily work with colleagues with colleagues and supervisor in a team environment
• Ability to effectively provide and accept feedback from colleagues based on sequential work reviews
• 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