Quality Engineer III
Core
Develops and implements quality plans, programs, and procedures using quality control statistics and lean manufacturing concepts to ensure product quality conforms to company, customer, and regulatory requirements.
Role type
Senior Quality Engineer (Medical Device/Injection Molding)
Builds
Quality evaluation and control plans, protocols, and validation/qualification programs for manufacturing processes.
Domain
Manufacturing (Medical Device/Injection Molding)
Required skills
Quality control statistics, Lean manufacturing, ISO 13485, ISO 9001, Root cause analysis, CAPA management, Process validation, Statistical analysis, Audit execution, Corrective action implementation
Preferred skills
ASQ CQE certification, Lean Six Sigma, Automated assembly, Cleanroom manufacturing
Technologies
Microsoft Office (Excel, Word, PowerPoint), Quality Management Systems software
Responsibilities
Develops and maintains quality evaluation and control plans; Analyzes inspection and testing processes and performs statistical analysis; Audits quality systems for deficiencies; Leads investigation teams for customer complaints and recurring discrepancies; Mentors Quality Engineers and trains employees on quality requirements; Implements changes to validation programs for continual improvement.
Seniority
Senior, hands-on IC with delegation authority