Sr Quality Engineer
Core
Ensures product and process quality for machining and secondary operations (anodizing, final pack) by partnering with cross-functional teams to confirm manufacturing processes, equipment, and documentation meet regulatory requirements.
Role type
Senior Quality Engineer (Manufacturing)
Builds
Medical device manufacturing processes and quality controls
Domain
Medical Devices / Regulated Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Statistical analysis, Root cause analysis, Risk assessment, Validation planning, CAPA management, Change control, Audit readiness, Process capability analysis, Technical writing
Preferred skills
Lean Six Sigma (Green/Black Belt), FDA/ISO 13485 knowledge, SPC, DOE, Minitab/JMP/Power BI, Python/VBA, Automation
Technologies
Minitab, JMP, Excel, Power BI, SAP, JDE, Factory Works, Python, VBA
Responsibilities
Define and implement quality controls for machining and secondary processes; Develop inspection, testing, and validation methods; Analyze data to evaluate process capability and investigate non-conformances; Ensure investigations and corrective actions are compliant and risk-based; Lead product lifecycle quality activities including change management and continuous improvement.
Seniority
Senior, hands-on IC
