Sr QC Engineering Assistant
Core
Set up and maintain incoming and outgoing quality inspection criteria, manage inspection plans in SAP, and support QC engineers in manufacturing operations to ensure compliance with quality standards and regulatory requirements.
Role type
Sr QC Engineering Assistant (Quality Assurance)
Builds
Quality inspection criteria, inspection plans, checklists, and compliance documentation for manufacturing operations.
Domain
Life Sciences / Medical Devices / Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
SAP QM configuration, incoming/outgoing inspection execution, cGMP compliance knowledge, quantitative data tabulation, audit support, ISO 9001/13485/21CFR Part 820 regulatory adherence, cross-functional collaboration
Preferred skills
TrackWise usage, Microsoft Office proficiency, CMM/SmartScope Instrument operation, NPI project support
Technologies
SAP QM, CAMSTAR, TrackWise, Microsoft Office, CMM, SmartScope
Responsibilities
Maintain inspection criteria and plans in SAP QM; support QC engineers with incoming material setup for NPIs; create and maintain inspection checklists for outgoing quality; support safety compliance and external regulatory audits; tabulate quantitative data for review; compile and verify quality inspection records and COC/COA; participate in quality improvement initiatives; ensure system compliance with ISO and FDA regulations.
Seniority
Mid-level, hands-on IC
