Quality Engineer  

Portland, OR

Reports To:  Director of Quality & Regulatory Affairs

Primary Function:  Lead, facilitate, and execute continuous improvement projects and product qualification and validation.

Job Duties:

  • Leads in process and product improvement activities and risk mitigation;
  • Manages process and sterilization validations;
  • Provides hand-on solutions for quality issues on the production floor;
  • Maintains databases and provides trending reports as needed;
  • Serves as Quality representative in Design Control activities;
  • Serves as Quality representative on the Materials Review Board and assists in the investigations of nonconformances;
  • Leads projects across multi-functional teams;
  • Assists in the resolution of customer complaints and corrective or preventive actions;
  • Assists in the development of purchased material, product, and packaging specifications;
  • Assists in the development of procedures, work instructions, and other quality documentation;
  • Assists in manufacturing equipment selection, IQ, OQ, and PQ;
  • Assists in internal and external audits;
  • Assists in cleanroom monitoring activities;
  • Assists in training company personnel to written procedures, specifications, etc., and to quality objectives;
  • Performs other duties as assigned by supervisor.

Education & Experience:

Requires a BS in engineering or related field, and a minimum of 5 years of experience in an FDA-regulated manufacturing environment.  Must have knowledge and experience with ISO 13485.  Must be knowledgeable of statistical sampling techniques and principles and have experience in product sterilization.  Additional coursework or certifications in related quality areas such as TQM, quality auditing, project management, Lean Enterprise, and Six Sigma is highly desirable. 

Skills:

Must be an expert in Microsoft Word, Excel, Access, and PowerPoint, and a demonstrable skill in project management.  Must be attentive to details with the ability to analyze situations and solve problems.  Must have excellent oral and written communication skills.  Must demonstrate a high degree of integrity, leadership, and ability to work in cross-functional teams. 

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