Quality Engineer
We're currently working with a leading Medical Device manufacturing company in the Fayetteville Area looking for a skilled Quality Engineer to join their team. 

Responsibilities:

• Provide Validation input (DOE, FAT, SAT) to cross-functional teams involving R&D, Marketing, Regulatory, developing medical devices.
• Support line transfers, qualification and verification activities at site
• Support supplier selection activities, address quality issues as they arise
• Develop statistically relevant test methods, protocols and documentation to support manufacturing of medical devices.
• Develop validated plans for joining operations like ultrasonic welding
• Conduct technical reviews; ensure documentation is available to meet Quality Systems Requirements. (BOMs, Routers, FMEAs, etc.). 
• Actively participates in concept review and development on new injection-molded products.
• Support various teams and work closely with Design Engineering and Project Management to smoothly transition new products to production. Provide frequent and appropriate communications with all internal customers
• Stay current on core competencies and best practices in manufacturing to ensure incorporation into new qualifications / validations.
• Identify root cause and implements corrective and preventive measures to improve or ensure product quality across product lines.
• Ensure product documentation and manufacturing processes meet all Quality system requirements.
• Designs, installs, and continually evaluate quality assurance and/or control methods and Systems.
• Conduct statistical analysis in the form of capability studies to evaluate processes.
• Develop standards, procedures, and work instructions.
• Apply in-depth knowledge of statistical techniques, with ability to identify, analyze and define possible solutions for continuous product and process improvement
• Perform training in internal auditing, mechanical inspection and statistical techniques
• Develop sampling plans and statistical methods to be utilized by manufacturing and inspection to include determination of control points and charting methods.
• Interface with engineering and CMM programmers to design fixtures and processes to ensure the effectiveness of measurement systems.
• Conduct internal and external audits and supplier surveys to verify capability and/or compliance.
• Coordinate and participate in material review activities to determine nonconforming product dispositions and corrective actions.

Requirements:  

• 4 year Engineering Degree and 5+ years of experience in the areas of quality management in the medical device field 
• Ability to apply engineering principles to an idea or set of user requirements and then convert this into design requirements, considering manufacturability, cost of goods, and the regulatory requirements for a device or combination product.
• Ability to develop injection molding and Assembly Validation Master plans.
• Expertise in plastics testing – particularly ASTM and ISO mechanical tests.
• Ability to make data-based and risk-based decisions to drive projects efficiently.
• Good understanding of Design for Manufacturability principals, GAMP5, UL and EU electrical standards.
• Expertise of FDA regulations and validation of automation equipment, i.e. SAT, FAT, IQ, OQ, PQ.