Descripción del Trabajo
- This position is responsible for final inspection and sealing of medical devices.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
- Operating a Heat Sealing Band Sealer
- Operating a Blister Pack Sealer
- Final inspection of devices provided by Inspection area prior to sealing
- Examine controlled documents to ensure all protocols are met
- Functionally test sealer daily to ensure standards are met and complete appropriate logs
- Organize and prioritize daily job orders
- Status Job orders in SIS System
- Locate Work Instructions (Protocols) in the computer
- Keep in compliance of safety measures including the use of gowns, gloves and all PPE
- Verify job number on traveler with job number on device labels
- Meet or exceed all quality and productivity expectations
- Ability to work, as needed, in other areas of production
- Able to work overtime as needed (including mandatory weekend overtime)
- Conduct associate training within the department as required
- Committed to building a positive culture
- Other responsibilities may be assigned & not all responsibilities listed may be assigned
- POLICIES: Know and follow policies and procedures and assure that direct reports know & follow policies & procedures related to work activities performed in area of responsibility
- TRAINING: Complete training in area of responsibility and assure that direct reports are trained in area of responsibility within allowed time-period. Training is required for changes in existing policies & procedures, for new assignments and for implementation of new policies & procedures. Complete required periodic re-training and assure that required periodic re-training takes place for direct reports in areas such as environmental health & safety
- SAFETY: Set standards for safe behavior. Recognize and reward safe behavior in others. Ensure that direct reports employ safe practices. Enforce safety policies & procedures. Evaluate staff member’s safety performance & insure that safety is a part of each direct report’s performance appraisal.
Education & Experience Requirements
- High School diploma or equivalent required
- Prior experience in the medical device industry is preferred
- Proficient in Microsoft Office
- Familiar with and able to navigate MES or New Critical Manufacturing System preferred
- Basic knowledge of FDA and ISO regulations preferred
- Willingness to learn and take on additional responsibilities
- Ability to build and maintain effective working relationships with diverse people and to promote teamwork/collaboration
- Able to follow verbal and written instructions
- Must have excellent hand and eye coordination/dexterity
- Ability to learn quickly and to identify, logically analyze, and solve work related problems
- Ability to learn overall understanding of process flow and resources within the organization
- Ability to maintain high work standards and concern for the quality of work; to work reliably and responsibly to improve daily
- Ability to read, write, count and understand English
- Ability to function independently as well as part of a team
- Excellent written and oral communication skills
- Ability to manage multiple priorities in fast-paced environment
Physical Requirements Needed to Perform Position Functions
- Lift/carry up to 20 lbs frequently and up to 50 lbs occasionally
- Push/pull, up to 100 lbs occasionally
- Bend up to 30 degrees, kneel/squat, sit, overhead reach occasionally
- Twist/turn, stand/walk and rotate activities/positions frequently
- Grasping – light and out-stretched arms both hands
Ability to operate a personal computer including using a Windows based operating system and related software. Ability to read and comprehend simple instructions, short correspondence, and memos. Ability to write simple correspondence. Read and understand visual aid.
Must be able to calculate quantity of parts to be prepped and ready for use at any time. Ability to add and subtract two digit numbers and to multiply and divide with 10's and 100's.
Ability to apply common sense understanding to carry out simple one- or two-step instructions. Ability to deal with standardized situations with only occasional or no variables.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Individual’s primary workstation is located on the manufacturing floor. The noise level in the work environment is moderate.