Essential Duties and Responsibilities:
- Perform sampling, inspections, and testing of in-process and finished goods products per applicable procedures and AQL plans, utilizing both visual means as well as calibrated test equipment to include laser micrometer, optical comparator and other equipment as applicable
- Release acceptable in-process and finished goods product for further processing and/or shipping as applicable per site
- Understand and follow applicable ISO standards requirements (ISO 15378 and 9001)
- Perform review of inspection records to assure product conforms to specifications and proper documentation practices
- Retains sample of finished products and maintains all applicable documents to form batch records and ensures appropriate batch records disposition (i.e. filing, scanning etc.) as necessary
- Print documents from Master Control, shopfloor or other software program and manages documents related to the Quality System
- Segregate nonconforming product and handle quarantined product and raw materials as applicable by site
- Generate rejection and deviation reports as directed by site
- Perform trace back investigation of nonconforming raw material and product as directed by site
- Promotes and supports a Lean environment.
- Conforms with and abides by all corporate and site-specific regulations, policies, work procedures, instruction, and all safety rules
- Exhibits regular, reliable, punctual and predictable attendance
- Other duties as assigned
Education and Experience:
- Must pass pre-employment testing; 1-3 years manufacturing experience preferred
Knowledge, Skills and Abilities:
- Must possess an acute attention to detail
- Basic computer skills, i.e. use a mouse/keyboard.
- Ability to apply Good Manufacturing Practices (GMP)
- General use of computer work station and ability to use SAP commands is preferred
- Must be willing and able to work as a team member and make general decisions within authorized job responsibilities
- Must be able to train and guide others as required.
- Must be able to read and write in English
Physical and Travel Requirements
- Ability to work standing for up to 12 hours per shift
- Frequent standing, twisting, bending, reaching, pushing, pulling as required by the job
- Ability to effectively communicate with team members on the work shift
- Be able to work near temperatures (250-350 degrees F) for short durations
- Pushing or pulling of wheeled objects weighing 500+ lbs. or less for short periods of time and/or over short distances, and lifting of up to 15 pound repeatedly throughout shift.
- Must be able to gown into required clothing for a controlled clean room
- Must be able to pass color vision and visual acuity test to 20/30 with corrected or uncorrected vision
- Must also be able to tolerate industrial odors and smells on a frequent basis
- Travel is <5% as needed