• Understands and applies typical Quality Management System structures (ISO 9001) and develops and implements processes, documentation, quality records, etc. Performs audits of the QMS and manages the audit process. Can participate or facilitate Audits performed by Regulatory Agencies.
• Leads quality department in new product / process development utilizing company processes and industry standards such as PFD, PFMEA, Control Plans, etc.
• Defines, identifies, and applies product and process control methods such as developing control plans, identifying critical control points, developing and validating work instructions, etc.
• Defines and implements continuous improvements for products and processes based on industry standard practices such as Six Sigma, PDCA, Lean, etc.
• Selects, constructs, applies, and interprets quantitative methods and tools – data collection and analysis, descriptive and inferential statistics, probability distributions, SPC, process and product capability, DOE.
• Identifies opportunities and implements corrective actions through structured problem solving methods including 5 why, 8D, CAPA. Facilitates others in performance of these activities.
• Identifies, describes, and applies metrology techniques such as calibration systems, measurement system analysis, and general measurement techniques.
• Interfaces with customers and suppliers to address quality issues; ability to use company systems for managing customer complaints and supplier quality (Oracle based).
• Participates in the interviewing process and provides input to hiring decisions.
• Performs as back up to the Quality Manager as assigned.
• Control and reduction of Quality Cost.
Education, Knowledge, Skills, Training, and Experience:
• College Degree required, technical degree preferred
• CQA / CQE preferred
Minimum of 8 years of quality engineering experience, required; minimum of 5 years quality engineering experience in a manufacturing environment, required.
Word, Excel, Power Point, MS Project, VISIO), Oracle, SharePoint, P-lion, Gage Track, Minitab.
1.5 Certification Deseable (ASQ, Six Sigma, Lean Manufacturing, etc.)