Mfg/Ops Quality Engineer 1
Core
Support day-to-day sustaining activities, continuous improvement, and capacity expansion in a regulated in-vitro diagnostic manufacturing environment.
Role type
Junior manufacturing quality engineer (regulated environment)
Builds
Manufacturing processes and validation programs compliant with FDA and ISO standards
Domain
Life sciences / In-vitro diagnostics manufacturing
Required skills
Quality regulations (21CFR 820, ISO 13485, ISO 14971, IVDD), ERP system quality controls, validation planning and transfer, non-conformance management, process risk management, GMP compliance review, data trend analysis
Preferred skills
SAP experience, in-vitro diagnostic manufacturing experience
Responsibilities
Provide ongoing quality engineering support throughout the product life cycle; Support engineering and manufacturing functions for validation planning and transfer activities; Ensure adequacy of non-conformances and QI/CAPA records, investigations, and corrective actions; Support process risk management activities and ensure quality and completeness of validation packages and change orders; Review verification and validation reports and identify gaps for GMP compliance; Develop and execute strategies to close gaps in an efficient, technical, and compliant manner; Coordinate issue resolution using a risk-based approach; Trend, analyze, and report on quality data to improve product and process
Seniority
Junior (0-2 years experience)