The Quality Engineer assists in the development and operation of quality control systems, application and analysis of testing and inspection procedures, the ability to use metrology and statistical methods to diagnose and correct improper quality control practices.

Essential Duties and Responsibilities:

• Devises sampling procedures, and designs and develops forms and instructions for recording, evaluating, and reporting quality and reliability data.
• Works with Materials/Purchasing Department to assure acceptable supplier quality and delivery.
• Lead product and process risk assessment.
• Knowledge and utilization of SPC, FMEA, MSA, and Control Plan development.
• Ability to work with team to gather information to write Validation Protocols, Final Reports, Master Plans for Process Validation and Product Qualifications.
• Conduct data collection, data analysis, and trending.
• Assist and/or lead in thorough investigations of quality issues and effective corrective and/or preventative action.
• Lead product scale-up for process capability and statistical relevancy.
• Expertise to effectively communicate within all levels of the organization around concepts of design controls, design verification and validation activities; production and process controls; Corrective & Preventive Action (CAPA), complaints & risk management; product quality improvement and root cause analysis.

Knowledge, Skills, Competencies, and Abilities:

• Six Sigma Green Belt preferred
• ASQ Certified Quality Engineer (CQE) preferred
• Familiarity with production processes, standard mechanical, metallurgical, and electrical test methods, SPC, ISO 9001 015 requirements.
• Must possess a strong sense of urgency, teamwork, keen attention to detail, ability to plan, organize and multi-task.

Required Qualifications:

• ?Bachelor's degree in Engineering (Quality or Industrial Preferred) or other related field
• 2+ years of experience in a similar role preferred
• Quality management systems experience (ISO 9001:2015)