Quality Engineer

ATS Corporation•Indianapolis, IN

3d•Onsite

About The Position

The Quality Engineer supports Comecer Project Managers in the management of the 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 role involves supporting the drafting and finalization of technical documents, ensuring compliance with legal, regulatory, and project requirements, and managing the quality aspects of orders including specific validation (DQ), validation documentation, and process controls. The position requires collaboration with the technical team, third parties, and customer sites to perform and complete SAT, IQ, OQ, VPHP Cycle development, and VPHP PQ activities. Additionally, the role involves developing and maintaining quality procedures and controls at Comecer Inc. facilities in North America, establishing regulatory approval for Comecer disposable kits, developing inspection methods, implementing systems for conformity and accuracy, ensuring product compliance with standards and specifications, and planning/documenting control activities and inspections.

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 able to meet deadlines for responsibilities.
Ability to stand, walk, push, pull, reach overhead, and bend to the floor.
Ability to exert up to 50 pounds of force occasionally, and/or exert up to 10 pounds of force frequently.
Normal visual acuity for reading written instructions and computer screens.
Normal hearing ability for understanding verbal instructions.
Capable of wearing appropriate related PPE for extended periods of time.

Nice To Haves

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

Responsibilities

Support Comecer Project Managers in the management of orders from a quality perspective throughout the project lifecycle.
Involve in design reviews, FAT, SAT, IQ, OQ, and aspects of PQ related to VPHP cycle development.
Support the drafting and finalization of technical documents and interpretation of legal, regulatory, and project requirements.
Manage quality aspects of orders, including specific validation (DQ), validation documentation, and process controls.
Collaborate with the technical team, third parties, and customers at customer sites to perform and 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 meet customer and regulatory requirements.
Work with Comecer quality personnel and third 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 comply 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.
Perform other duties as required.