Supplier Quality Engineer

Supplier Quality Engineer

Location:

Noblesville, IN, United States, 46060

Date:
Jun 16, 2026

Curium is the world's largest nuclear medicine company with more than a century of industry experience. We develop, manufacture and distribute world‑class radiopharmaceutical products to help patients around the globe. Our proven heritage combined with a pioneering approach is the hallmark for delivering innovation, excellence and unparalleled service. With manufacturing facilities across Europe and the United States, Curium delivers SPECT, PET and therapeutic radiopharmaceutical solutions for life‑threatening diseases to over 14 million patients annually.

The Supplier Quality Engineer position is responsible for assisting with the Supplier Quality Program in compliance with applicable regulations. Responsibilities include supplier evaluations, Quality Agreements, corrective actions, vendor changes, metrics, filing and scanning documents. The role also participates in the internal auditing program and supports site regulatory inspections and customer audits.

Monday – Friday 7:30 am – 4:00 pm; hours may be adjusted.

• Maintain operational compliance with US and international regulatory agencies and guidelines (e.g., FDA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP).
• Conduct supplier evaluations, including assessments via questionnaire and audits.
• Issue supplier complaints and drive resolution and corrective action.
• Develop and maintain Supplier Quality Agreements.
• Perform initial assessment of vendor changes, route for functional reviews, and track to completion.
• Participate in internal audits and assess subsequent corrective action recommendations.
• Provide support for FDA and other regulatory inspections and customer audits.
• Perform filing and scanning of documents.
• Execute and deliver on assigned project tasks in accordance with established timelines.
• Ensure a safe and quality working environment through training, awareness and compliance to regulatory guidelines and procedures.

• Bachelor of Science in Life Sciences or Engineering, or equivalent experience.
• Three or more years of relevant experience in a pharmaceutical/medical device manufacturing environment with strong understanding of applicable quality systems.
• Knowledge of cGMP guidelines and their application in a controlled aseptic environment (preferred).
• Awareness of quality systems including Change Control, Internal Auditing, Corrective Action Program, Deviation and Complaint investigations, and Document Management.
• Experience with statistical tools.
• Proficiency in Microsoft Office suite.
• Strong problem‑solving, decision‑making, verbal and written communication skills.
• Results‑oriented, able to prioritize work in a fast‑paced environment.
• Independent judgment in planning, organizing, and performing tasks.
• Excellent communication and motivation skills for cross‑functional collaboration.
• Ability to work with other groups to resolve issues and achieve compliant outcomes.
• Ability to positively influence diverse populations within and outside the organization.

• Willingness to work in a plant producing radioactive materials and to participate in safety programs designed to minimize exposure.
• Physical tasks include lifting up to 70 pounds, kneeling, crouching, twisting, walking, bending, stooping, pushing, pulling, reaching, and negotiating stairs and evacuation ladders.
• Use of hand truck, forklift, and conveyors when possible; proper lifting techniques required.
• Willingness to wear personal protective equipment (PPE) and hearing protection as needed.
• May be required to sit or stand for long periods (8+ hours) while performing duties.
• Requires good hand‑eye coordination and close attention to detail.
• Work indoors and outdoors with exposure to mechanical/moving parts, corrosive, flammable and toxic materials, dust, dirt, odors, and irritants.
• Willingness to complete safety training within allotted time frames and to work in a team‑based environment.
• Availability for outside regular hours, including off‑shift, weekend, and holiday work as business needs require.

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.

Curium is an equal opportunity employer and believes everyone deserves respect, dignity and equality. All applicants will be considered for employment without consideration of race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.

Nuclear Engineering, Medical Technologist, Facilities, Medical Device Engineer, Forklift, Engineering, Healthcare, Operations, Manufacturing