Quality Engineer

Responsibilities:

• Works in Quality Engineering role with other functional groups, provides support of new process/ product and transfer products
• Works as the primary quality contact for the Customer during the NPI process
• Provides NPI Team direction, analysis and recommendations to assure effective quality control and associated risk management plans
• Writes Master Validation Plan to define overall NPI validation activities
• Writes, reviews and/or approves process and product validation protocols and reports, equipment qualifications, engineering change orders
• Provides technical leadership for Failure Mode and Effects Analysis (FMEA) and Control Plans for Process FMEA's
• Owns the FMEA process
• Supports complaint investigations as appropriate
• Develops, writes and helps execute Test Method Validations
• Assures proper use of statistical tools to analyze data, make acceptance decisions, and improve process capability (DOE, SPC), throughout the organization
• Ensures that development activities follow control requirements and product is properly transferred to manufacturing
• Assures all control plans meet necessary requirements to ensure effective product acceptance including appropriate inspection requirements, equipment and gage requirements and sampling plans
• Initiates and investigates Corrective and Preventative Actions (CAPA) as appropriate
• Assures Operation Value Stream quality activities remain in compliance with FDA / ISO regulations/standards/guidelines and facility SOP's and Customer requirements
• Leads continuous improvement activities and supports Lean environment and re-work/scrap reduction
• Supports annual Quality Improvement goals with Operations and Quality Leadership