Quality Engineer

This position is responsible for developing and maintaining quality engineering methodologies and providing quality engineering support for our custom product realization process. Working with manufacturing engineering, production, and quality to deliver exception quality process to the factory floor.

• Identify and implement effective process control systems to support the qualification and ongoing manufacturing of products in order to meet and exceed internal and external requirements.
• Lead our team in the implementation of process controls, CAPA systems, resolve any quality issues.
• Assist in the streamlining of our manufacturing process to incorporate lean and six sigma methods on the manufacturing floor. Improve business systems to effectively identify and resolve quality concerns.
• Utilize sound systematic problem-solving methods, prioritizing and communication quality and efficient manufacturing process as well as lead and implement Process Improvements (i.e. Six Sigma, Lean manufacturing, 5 whys etc.) Support product sustaining activities in the areas of change management, ISO compliance, quality control, and supplier management initiatives.
• Work with management to execute projects that improve the QMS (Quality Management System).
• Administer internal audit, calibration, and corrective action programs in compliance with QMS procedures and ISO standards.
• Participate and sometimes lead the completion and maintenance of risk analysis.
• Lead investigations, resolution, and prevention of product and process non-conformances.
• Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS) Environmental management Systems (EMS) and other regulatory requirements.
• Comply with company policies, operating procedures, processes, and task assignment. Maintains positive and cooperative communications and collaboration with all level of employees, customers, contractors, and vendors.
• Performs other related duties and responsibilities, on occasion as assigned.
• Participate and lead Material Review Board (MRB) process to determine disposition decisions on non-conforming parts
• Manage, maintain, and track calibration of quality tools used throughout the business.
• Participate in cross-functional teams across the business to improve business processes and systems.
• Partner with manufacturing to build quality into standard work and establish mistake proofing activities to reduce finished goods inspection requirements.

• Bachelors Degree:
  Engineering or Science discipline or equivalent experience
• Needs to have 5+ years quality experience in an electronics/electro-mechanical manufacturing environment
• Must be a legal US Citizen
• Working Knowledge of appropriate regulatory agencies AS9100, EN13485, ISO
  9001
• Experience and expertise in investigating root cause analysis, CAPA, SCAR
• Experience utilizing tools such as six-sigma, lean, 8-D, CAPA, PFMEA, 5 Whys etc.
• Internal Audit Experience