What are the responsibilities and job description for the Senior Quality Engineer position at iStaff?
Our client, a leader in radioisotope production and advanced cancer treatment technologies, is seeking a Senior Quality Engineer to support quality and compliance efforts within a highly regulated manufacturing environment. This role will partner cross-functionally with production, engineering, regulatory, and technical teams to ensure processes, documentation, and products meet FDA/cGMP and internal quality standards.
Key Responsibilities
- Provide quality oversight for radioisotope/radiopharmaceutical manufacturing and related production activities
- Maintain and improve quality systems including CAPA, deviations, change control, and document management
- Develop/review SOPs, batch records, validation protocols, technical reports, and manufacturing documentation
- Support process validation, equipment qualification, and analytical method validation efforts
- Participate in internal audits, inspections, and regulatory readiness activities
- Lead investigations into deviations/nonconformances and drive root cause / corrective actions
- Support regulatory documentation including DMFs and other submission-related quality documentation
- Partner with technical teams on process improvements, technology transfer, and scale-up initiatives
Qualifications
- Bachelor’s degree in Chemistry, Chemical Engineering, Biomedical Engineering, Pharmaceutical Sciences, or related discipline
- 5 years of quality engineering/QA or validation experience in a regulated manufacturing environment (ideally in radiochemistry, radioisotope production or nuclear materials handling)
- Strong knowledge of FDA, cGMP, and quality systems
- Experience with process validation, equipment qualification, CAPA, and deviation investigations
- Background in pharmaceutical, radiopharmaceutical, medical device, nuclear materials, or related regulated industries preferred
- Experience supporting regulatory filings and/or Drug Master Files (DMFs) preferred
- Strong technical writing, documentation, and proficiency with Microsoft Office and electronic quality management systems (QMS)