Nucleus RadioPharma · 1 day ago
Quality Engineer
Rochester, MN
Full-time
Onsite
Senior Level
$100K/yr - $125K/yr
6+ years expNucleus RadioPharma is a company focused on radiopharmaceutical manufacturing, and they are seeking a Quality Engineer to ensure compliance with cGMP and regulatory standards. The role involves providing quality oversight, managing deviation investigations, and supporting validation and qualification processes in manufacturing operations.
Health Care
Responsibilities
Lead and own deviation investigations, root cause analysis, and the development and effectiveness of corrective and preventive actions (CAPA)
Provide quality oversight for process validation, equipment qualification, aseptic processing, and cleanroom operations, ensuring adherence to approved protocols and regulatory expectations
Support site readiness activities including facility and cleanroom qualification, process startup, and introduction of new or modified manufacturing processes from a quality perspective
Review and approve GMP documentation, including protocols, reports, procedures, and technical change records, ensuring data integrity and compliance
Support internal, client, and regulatory audits and contribute quality input to regulatory submissions
Drive continuous improvement initiatives focused on compliance robustness, inspection readiness, and right-first-time manufacturing
Develop, implement, and maintain quality procedures, processes, and documentation in compliance with relevant industry regulations and standards (e.g., FDA, ISO, GMP, USP)
Conduct internal audits and support external audits/inspections by clients and regulatory agencies
Participate in the management of the QMS, including document control, training, and record-keeping
Review and approve project documents, protocols, and reports related to process validation, equipment qualification, and test methodologies
Support validation activities for manufacturing processes, equipment, utilities, and cleanrooms
Collaborate with Manufacturing, MSAT, and QA teams to maintain quality control measures on the production floor
Investigate and document quality issues, deviations, and non-conformances; support root cause analysis and corrective/preventive actions (CAPA)
Lead investigations into quality issues, customer complaints, and non-conformities to identify root causes using systematic problem-solving methodologies
Track and trend quality data to identify recurring issues and opportunities for improvement
Review and approve incoming materials, supplier documentation and change controls as appropriate
Author, review, and approve regulated documents, including standard operating procedures (SOPs), test protocols, and reports
Assist in supplier qualifications and audits to ensure compliance with quality standards
Provide training and guidance to staff on quality assurance principles, and procedures
Maintain accurate, compliant records of quality processes, procedures, and activities
Ensure compliance with applicable quality and regulatory requirements (21 CFR 210/211/212, USP , EU GMP Annex 1 as applicable, and NRC, DOT Class 7).- Serve as SME during inspections and regulatory interactions
Select, commission, and validate radiosynthesis platforms, hot cells, and automation systems, support training on new technologies
Oversee transfer documentation (URS, pRA, PQ) and deploy MES/eBR, LIMS, and quality-by-design solutions for data integrity and review-by-exception
Implement digital analytics to increase transparency and manufacturing efficiency
Partner with Supply Chain to secure consumables, spare parts, and critical materials
Apply ICH Q9 risk management to proactively address compliance and operational challenges
Drive continuous improvement to stabilize processes, enhance yield, and reduce cost without compromising safety or quality
Ensure radiation safety and ALARA compliance in partnership with RSO and EHS
Qualification
Required
Bachelor's degree in engineering (e.g., Chemical, Biomedical, Mechanical, Electrical), Chemistry, Life Sciences, or equivalent, or related field
A minimum of 6 years of experience in a Quality Engineering or Quality Assurance role within a regulated industry, preferably medical devices or pharmaceuticals
Experience with radiopharmaceuticals is highly desirable
Strong knowledge of cGMP regulations and pharmaceutical quality systems (e.g., FDA 21 CFR Parts 210/211, 820, Part 11 and Annex 1)
Familiarity with GxP, compliance and phase-appropriate validation requirements
Experience with risk management tools and methodologies (e.g., FMEA, risk assessments, hazard analysis)
Proficiency in root cause analysis, statistical analysis, and other structured problem-solving methods
Knowledge of validation and qualification techniques for processes, equipment, utilities, software, and cleanrooms
Excellent written and verbal communication skills
Highly collaborative, strong decision-making capabilities
Strong analytical, problem-solving, and critical thinking abilities
Highly organized with strong attention to detail
Ability to work independently and collaboratively in a cross-functional team environment
Strong project management skills, with the ability to prioritize and manage multiple tasks
Preferred
A master's degree or relevant certification (e.g., ASQ Certified Quality Engineer - CQE) is a plus
Familiarity with radiation safety principles (e.g., ALARA) is preferred
Benefits
Medical, dental, and vision insurance
Health Savings Account or Flexible Spending Account options (depending on the plan chosen)
401k retirement account access with employer matching
Paid sick leave and/or other paid time off in compliance with applicable law
Relocation is available to qualified team members
Company
Nucleus RadioPharma
Nucleus RadioPharma is a new company built to ensure cancer patients can access potentially life-saving radiopharmaceuticals.
11-50 employees
H1B Sponsorship
Nucleus RadioPharma has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
2024 (2)
Funding
Current Stage
Early StageTotal Funding
$62MKey Investors
Eclipse Ventures,GE HealthcareEclipse Ventures,Mayo Clinic
2024-06-05Series A
2023-10-17Series A· $56M
2022-10-12Seed· $6M
Leadership Team
Stephen Hahn
Chief Executive Officer
Recent News
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