Job Description
Calibration Technician
Must be able to calibrate instruments that measure:
· Distance
· Volume
· Pressure
· Vacuum
· Density
· Measurements one thousand of an inch ( 0.0001 )
· Work with outside qualified calibrations companies/agencies
SECTION 1:
JOB SUMMARY* Maintains and improves the status of equipment and components key to manufacturing and measuring medical and other devices. Performs calibration duties and supports manufacturing, packaging operations, and facilities.
SECTION 2: DUTIES & responsibilities under limited supervision/general direction and following all applicable federal, state, and local laws/regulations and corporate procedures and guidelines, for this position:
- Performs scheduled routine and nonscheduled calibrations on production and facilities equipment.
- Evaluate and update calibration standard operating procedures.
- Suggests improvements to existing standard operating procedures for calibration methods and systems.
- Develops increased knowledge of the manufacturing process and equipment operation to help to identify calibration needs.
- Maintains the calibration status of all measuring and critical manufacturing equipment.
- Assists in establishing calibration and test methods for new and existing equipment. Completes accurately all calibration test records.
- Raises issues and reports on calibration failures.
- Develop new standard operating procedures for calibration of new equipment. x Revises standard operating procedures as required.
- Ensures that calibration records are updated and stored such that they are easily retrieved. x Responsible for communicating business-related issues or opportunities to the next management level.
- Responsible for ensuring personal and Company compliance with all Federal, State, local, and Company regulations, policies, and procedures. x Demonstrate independent understanding and application of core GMP fundamentals, including but not limited to Data Integrity (DI), Good Manufacturing Practices (GMP), and Good Documentation Practices (GDPs).
- Performs other duties assigned as needed.
SECTION 3: EXPERIENCE AND EDUCATION
· Requires 2-4 years related experience.
· Associate’s degree or Equivalent.
· Experience in the Medical Device industry or medical field is preferred.
REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS
- Competent communication skills, both written and verbal are required.
- Technical writing skills preferred.
- Good organizational skills and the ability to handle multiple tasks required.
- Demonstrated knowledge of manufacturing principles practices, and procedures. Maximo software experience preferred.
- Ability to communicate effectively with a diverse clientele base.
- Ability to work cooperatively with coworkers and the public.
- Ability to perform duties following policies and procedures.
- Ability to work a flexible schedule including overtime with minimal notice.
- Ability to work in a class 10,000 clean room.
- Ability to wear cleanroom gowns.
- This position will be performed in a clean room production environment which requires certain preparation and gowning practices.
Location: Irving, Texas
