Quality Engineer, Validation & Regulatory Compliance

ATS Corporation; Indianapolis (IN); On-site; USD 65,000 - 85,000; Full time

Job summary

Comecer Inc. is seeking a Quality Engineer to support project managers across North America, ensuring quality throughout design reviews, FAT/SAT/IQ/OQ activities, and PQ development for VPHP cycle projects in Radiopharma, Pharma and ATMP sectors.

The role involves collaboration with field teams and 3rd parties to ensure regulatory compliance, develop inspection methods, and maintain quality procedures at North America facilities. Strong documentation and ISO 9001 experience are preferred.

Qualifications

• Bachelor’s degree in a technical field or equivalent experience.
• Quality Engineering experience in a manufacturing environment.
• Experience with International Standardization Organization (ISO) standards 9001 preferred.
• Ability to communicate efficiently and effectively with people at all levels of the organization, both verbally and in written form.
• Strong problem-solving ability.

Responsibilities

• Draft and finalize technical documents and interpret regulatory requirements.
• Manage quality of orders including validation activities.
• Maintain and manage validation documentation.
• Oversee SAT, IQ, OQ, and PQ activities with field teams and third parties.
• Develop and maintain quality procedures and controls at Comecer Inc. facilities in North America.
• Collaborate to obtain regulatory approvals for Comecer disposable kits in North America.
• Develop inspection methods to analyze product quality.
• Implement a system to ensure production conformity and accuracy.
• Ensure compliance with quality standards and product specifications.
• Plan and document control activities and inspections.
• Perform other duties as required.

Skills

Quality Engineering

Manufacturing

ISO 9001

Regulatory Compliance

Documentation

Microsoft Office

Education

Bachelor’s degree in technical field

Tools

Microsoft Office

Job description

Comecer Inc. is seeking a Quality Engineer to support project managers across North America, ensuring quality throughout design reviews, FAT/SAT/IQ/OQ activities, and PQ development for VPHP cycle projects in Radiopharma, Pharma and ATMP sectors.

The role involves collaboration with field teams and 3rd parties to ensure regulatory compliance, develop inspection methods, and maintain quality procedures at North America facilities. Strong documentation and ISO 9001 experience are preferred.