Calibration Engineer I (On-Site | Austin, TX)

Artivion, Inc.•Austin, TX

12h•Onsite

About The Position

Utilizes Quality Engineering techniques to ensure that Artivion complies with all applicable federal, industry, and corporate procedures, guidelines, and regulations for calibration during the receipt, use, storage, manufacture, and distribution of products. Ensures that all areas outlined under “Principal Responsibilities” are accomplished in an efficient, professional manner to support Artivion, Inc.

Requirements

Minimum of a Bachelor’s Degree in engineering field or equivalent experience.
Minimum of 1-year hands-on calibration experience; preferably in an FDA regulated industry (i.e., pharmaceutical, biomedical, medical device field) with an in-depth knowledge of current Good Manufacturing Practices, Quality System Regulations, and ISO Standards.

Responsibilities

Assist in the implementation of corporate policies and procedures relating to quality, project management, process development, and Quality System Regulation/ISO compliance by periodically reviewing specifications for functionality and initiating the required changes, establishing procedures and integrated program plans for achieving reliability in accordance with specifications and procedures.
Plan, prepare, and execute calibrations and analyze data to approve equipment and processes used in the testing, processing, storing, and distribution of products.
Collect, statistically analyze calibration data.
Assist in the development, implementation, and documentation calibration activities to ensure that the products processed are proven to be reliable, safe, and effective prior to release.
Effectively complete “other” functions that may be assigned.