Quality Engineer

Responsibilities:

• Establish and maintain master validation program, including site and individual products and process master validations
• Create/Review/Support validation protocols and reports to support process and reliability improvements
• Support complaint handling program, including complaint analysis, investigation, and follow up
• Lead and/or support reliability and process improvements projects from quality perspective
• Establish and maintain process controls/SPC for specific production processes
• Support corrective and preventive action (CAPA) program
• Review and modify product designs and process documentation for quality characteristics, including manufacturability, serviceability, testability, reliability, and conformance to product and quality system requirements
• Demonstrate product compliance for sterilization, biocompatibility, package integrity, shelf life, reliability, and electrical safety
• Review and provide feedback of protocols and reports, test vendor qualification, and testing management
• Assist with the development and maintenance of product risk management files
• Assist with design verification testing and test method assessment and validation activities
• Recommend requirements for first article inspection, incoming and in-process inspections, and lot releae testing, including sampling strategy and test methods
• Participate in failure investigations to analyze internal system or process failures and to implement corrective and preventive action
• Participate in component and service new supplier evaluation. Works with suppliers to ensure appropriate quality controls are implemented
• Audit Design History Files and works with cross functional team to resolve documentation issues
• Identify and implement good Quality Engineering practices, including statistical methods and root cause analysis tools
• Participate in supplier material related processes which include coordination of MRB activities to ensure the timely assessment of potential non-conforming products
• Support continuous product and process improvement through detailed failure analysis for non-conformances, and investigates, develop, and implements effective and compliant solutions for product or process corrections, retrospective and remediation action plans, and for corrective and preventive actions
• Demonstrate the ability to implement ISO 14971, including risk evaluation techniques

Requirements:

• Bachelor's degree preferably in an engineering or scientific discipline from a four-year college or university
• 5+ years related experience and/or training; or equivalent combination of education and experience Medical Device or Class II device experience preferred, will consider experience from other regulated industries such as pharmaceutical, military or nuclear
• A working knowledge of the FDA Quality System Regulation, ISO 13485, ISO 14971, ISO10993,ISO 11135, and the EU Medical Device Directive is a plus
• Familiarity with test methods and standards for the design, verification, and validation of medical device products is required
• Experience with PPAP, PMEA