Quality Engineer

ATS Automation•Indianapolis, IN

6d•Onsite

About The Position

The Quality Engineer supports Comecer Project Managers in the management of orders from a quality point of view throughout the project, including design reviews, FAT, SAT, IQ, OQ, and some aspects of PQ as they relate to VPHP cycle development. The markets this position services include Radiopharma, Pharma, and Cell & Gene Therapy (ATMP) projects in North America. This includes a wide range of specialized equipment such as shielded hot cells, automation, synthesis and dispensing modules, isolators for various applications (sterility testing, potent API processing, cell culture), VPHP generators, solid target processing systems, dose calibrators, and aseptic filling lines.

Requirements

Bachelor’s degree in a technical field or equivalent experience.
Ability to communicate efficiently and effectively with people at all levels of the organization, both verbally and in written form.
Strong problem-solving ability.
Proficient in Microsoft Office suite.
Must be hands-on and must be able to meet deadlines for his or her responsibilities either directly or indirectly.

Nice To Haves

Quality Engineering experience in a manufacturing environment.
Experience with International Standardization Organization (ISO) standards 9001.

Responsibilities

Support colleagues in drafting and finalizing technical documents and the interpretation and application of legal, regulatory and project requirements.
Quality management of orders in relation to specific validation (DQ), validation documentation, and process controls.
Work with the technical team in the field as well as 3rd parties at customer sites to perform and successfully complete SAT, IQ, OQ, VPHP Cycle development, and VPHP PQ activities.
Develop and maintain quality procedures and controls at Comecer Inc. facilities in North America to conform to customer and regulatory requirements.
Work with Comecer quality personnel and 3rd parties to establish regulatory approval for Comecer disposable kits for sale in North America.
Develop inspection methods to analyze product quality.
Implement a working system to ensure conformity and accuracy in the production process.
Ensure products compliance with company and international quality standards.
Ensure that the product corresponds to the desired technical specifications and take corrective action to resolve non-conformities.
Plan and document control activities and inspections.
Other duties as required.