Engineer I, QA
Core
Maintain product quality and strengthen quality systems across the Rockford site by managing quality activities, investigating issues, and ensuring compliance with ISO and internal requirements.
Role type
Entry-level Quality Assurance Engineer (Manufacturing)
Builds
Pharmaceutical/biotech products and processes
Domain
Life Sciences / Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Analytical problem-solving, attention to detail, written and verbal communication, ability to manage multiple priorities
Preferred skills
Experience with quality systems and documentation, knowledge of ISO quality management systems, experience working with internal or external customers
Technologies
None stated
Responsibilities
Support site Quality Assurance activities to help maintain compliance with ISO and internal quality system requirements; Manage engineering change notices and deviations, and lead quality investigations involving customer complaints, product integrity concerns, and other quality issues through timely and effective resolution; Collaborate with cross-functional teams to address quality issues, respond to customer needs, and support business objectives; Support internal and external audits, ISO certification activities, and continuous improvement efforts; Support raw material reviews and incoming inspection activities to help ensure continued product quality; Develop and maintain quality and product documentation, including procedures, Certificates of Analysis templates, customer surveys, specifications, and product information; Collect and analyze quality data, provide training on quality procedures, and contribute to process and quality system improvements; Participate on cross-functional teams supporting new products, product changes, validations, and other operational initiatives
Seniority
Entry-level (1+ years experience)
