Associate, Quality Assurance Engineering
Core
Leading Quality Operations personnel to ensure compliance with Quality Systems in production areas and supporting the overall product life cycle.
Role type
Quality Systems Engineer (QSE)
Builds
compliant pharmaceutical/medical device products
Domain
Healthcare / Manufacturing / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
supervising team members, monitoring product quality, resolving non-conformances, conducting audits, managing supplier relationships, troubleshooting complex quality issues, integrating quality control results into manufacturing, adhering to GxP regulations
Preferred skills
continuous improvement culture, cross-functional collaboration
Technologies
GxP regulations, ISO standards, Standard Operating Procedures (SOPs), batch production records
Responsibilities
Directly supervise team members to ensure efficient task completion and adherence to processes; Monitor product quality at various manufacturing and distribution stages; Resolve non-conformances, maintain documentation and records, and review batch production records; Conduct audits, manage inspection and test results, and verify rejected products; Make release decisions and manage supplier relationships; Support Quality Assurance operations and ensure compliance with current Good Manufacturing Practices (cGxP), International Organization for Standardization (ISO) standards, and other regulations
Seniority
Individual Contributor, operational level
