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Spectrum Plastics Master Quality Engineer in Sandy, Utah

Essential Duties/Responsibilities:

  • Ensure operational processes and quality requirements meet customer expectations, update as required and clarify customer requirements when necessary.

  • Provide support to engineering, inspection, manufacturing, purchasing, and sales functions to achieve SPG team goals.

  • Assist in the project development phase of products by specifying first article submission requirements. This includes dimensional analysis, capability studies, customer forms, and required certifications.

  • Initiate corrective/preventive action when necessary.

  • Process incoming, in-process, finished, and customer returned discrepant material according to the Non-Conforming Material and Corrective Action procedures.

  • Support MRB meetings for rejected product.

  • Support the problem resolution process by acting as resource for quality problem solving methodology.

  • Respond with documented closed loop corrective action to internal and external quality problems when appropriate.

  • Lead and/or support continuous improvement efforts including 5S.

  • Participate in CAPA root Cause investigation and action implementation.

  • Prepare Quality related deliverables in a timely manner.

  • Perform process and internal ISO audits.

  • Prepare and execute Engineering and Gage R and R studies as required.

  • Work directly with all levels of the organization to ensure conformity to standards (ISO 13485)

  • Perform training within all levels of the organization.

  • Create and maintain quality/inspection documents.

Position Requirements:

Position Requirements:

  • Applicable Bachelor’s degree and/or equivalent experience in a related field, and a minimum of 3 to 5 years directly related experience. Quality Assurance experience preferred.

  • Proficient in applicable quality principles including, but not limited to, statistics, sampling management, metrology, quality planning techniques, and closed loop corrective action.

  • Ability to problem solve, identify errors and deficiencies and perform research with limited guidance.

  • Ability to apply knowledge to job function using pre-established guidelines and instructions.

  • Accuracy, attention to detail, and thoroughness.

  • Proficient communication skills.

  • Proficient M/S Office computer skills, experience with Minitab is a plus.

  • Ability to comprehend and comply with company safety and quality standards.

  • Ability to follow oral and written instructions.

  • Ability to work within a Team orientated fast paced environment.

  • Familiar with Six Sigma, lean manufacturing, PFMEA, Process Control Plans, Process Risk Management and Product Qualification protocols.

  • Medical Device experience (specifically ISO 13485, GDP and QSR) and knowledge of Clean Room requirements preferred