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Quality Engineer

By January 20, 2023No Comments

ESSENTIAL DUTIES AND RESPONSIBILITIES

  • Formulates and maintains quality assurance objectives and coordinates objectives with production procedures in cooperation with the Manager of QA to maximize product reliability and minimize costs.
  • Devises sampling procedures, and designs and develops forms and instructions for recording, evaluating and reporting quality and reliability data consistent with company policies and procedures.
  • Works with Materials/Purchasing Department to assure acceptable supplier quality and delivery.
  • Works with Staff Managers and Sales/Marketing to assess customer satisfaction and address/resolve issues.
  • Plans, promotes, and organizes training activities related to product quality and reliability.
  • In conjunction with the Quality Manager, serves as a representative & directs ISO 9001-2008 (ANSI/ASQC Q9001-1994)
  • Lead product and process risk assessment
  • Knowledge 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

 

 

EDUCATION and/or EXPERIENCE:

  • BS in Engineering (Quality or Industrial Preferred) or related field of study
  • 5+ years of experience in a similar role
  • Quality management systems experience (ISO 9001)
  • Experience with PPAP, PFMEA, GD&T