Manufacturing Set up Technician - 3rd Shift

The primary purpose of this position is to set-up, maintain, operate, test and inspect product, and perform repairs on associated departmental equipment in conformance to FDA, GMP’s, ISO 13485 standards and finished product specifications. Minimize scrap generation from processes and promote workplace safety. Provide process information to management so production equipment may be optimized and/or process corrected. Assist with training of personnel to perform various functions within each assigned area. Facilitate work flow and ensure product quality is maintained.

Shift Details

• 11:00 pm to 7:00 am - Tuesday through Saturday

Responsibilities

• Perform scheduled preventive maintenance as assigned by supervisor according to the Preventive Maintenance schedule.
• Adhere to plant policies/procedures, department EHS rules, Good Manufacturing Practices (GMP’s), ISO 13485 regulations and Good Housekeeping procedures. Shall operate in a manner that protects the health and safety of its employees/visitors and operate in a manner that conserves energy, natural resources and protects the environment.
• Complete all pertinent paperwork pertaining to the finished product being produced according to established guidelines in the manufacturing procedures.
• Prepare and maintain required maintenance equipment records. Use of micrometers, dial calipers, and other precision measuring instruments to perform dimensional and physical inspections. Interpret engineering drawings, schematic diagrams, or formulas and confer with management or engineering staff to determine quality and reliability standards.
• Uses ANSI/ASQ Z1.4 sampling standard, part drawings, and specifications to determine inspection and testing required as well as acceptable quality levels.
• Selects products for inspection evaluation at specified stages in production process, performs various visual, dimensional, performance, mechanical, electrical, or chemical inspections per required characteristics.
• Report any unusual circumstances to supervisor and perform other miscellaneous duties as assigned.
• Basic computer skills with windows based programs.
• Responsible for the observation of department regulations and to use personal protective equipment (PPE) as required; must be safety conscious and Lockout/Tag-out trained.
• Transport hazardous waste to accumulation areas. Complete Annual Hazardous Waste (RCRA) refresher training.
• Cross-train and support where needed throughout the facility.

Qualifications

• High School Diploma or GED preferred. One year certificate from college or technical school (machinist, engineering technology); or equivalent combination of training and experience preferred.
• 3-4 years medical device manufacturing related experience or equivalent combination of training and experience preferred.

What is expected of you and others at this level

• Applies basic skills and techniques to complete routine tasks within assigned area
• Maintains appropriate licenses/training/certifications
• Works on basic and routine assignments
• Works within clearly defined Standard Operating Procedures and/or scientific methods
• Adheres to all quality guidelines
• Works under close supervision. All work is reviewed for accuracy
• Any deviation from the norm are approved by the supervisor before proceeding

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