Spectrum Plastics Master Quality Engineer in Sandy, Utah
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.
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