ZEISS needs to ensure accurately calibrated test equipment in compliance with GMP requirements of the FDA in order to provide consistently high-quality products to our customers.
Requirements
- Ability to interpret complex blueprints, through the understanding of ANSI/NCSL Z540-1and GMP regulations and specifications.
- Must have the know-how to operate and handle calibration tools and test equipment.
- Experience in using standard measuring equipment.
- Have a thorough understanding of procedures for documenting and maintaining QC records.
- Solid computer skills using Microsoft Word and Excel.
- Good part drawing interpretation skills preferred.
Responsibilities
- Manage the calibration system to ensure the Carl Zeiss Meditec products and tools conform to ANSI/NCSL Z540-1.
- Control a system that provides prevention of inaccuracies through detection of deficiencies and timely corrective systems.
- Negotiate and approve the contracts with outside calibration sources.
- Oversee the administration of the control system for calibrating specialized equipment (not on the contract) with regard to cost and time.
- Assist in the development and maintenance of the calibration procedure in compliance with ANSI/ NCSL Z540-1and traceable to the National Institute for Standards and Technology.
- Maintain accurate records and observe normal safety requirements.
- Analyze repair cost for damaged equipment; determine if in-hours repairs are possible and cost effective.
Other
- Maintain currency of and adhere to applicable GMP and ISO 13485 processes and procedures.
- Abide by state and federal employment laws.
- Maintain close communication with all department supervisors on calibration requirements.
- Analyze and resolve problems encountered during the regular course of equipment calibration.
- Arrange transport of equipment requiring calibration and/or repair with outside calibration vendors.
