Quality Engineer I with CMM Experience

Position Summary

The Quality Engineer I will interact with team members to ensure compliance and internal and external customer requirements are met, with focus on quality engineering. This will be accomplished within Tecomet’s principles of continuous improvement, customer driven innovation and a win first culture, while meeting company financial and other performance metrics.

Principle Responsibilities

• Maintain applicable quality system, environmental, and FDA requirements/certifications.
• Facilitate operator owned quality program.
• Serving on the MRB and RMA processes.
• Work with team members and support manufacturing/operations to solve quality, cost and schedule issues.
• Prepare FMEA’s, controls plans, quality plans, PPAP.
• Cookordination process validations and reduce dependence on inspection.
• Generate applicable quality metric reports; cost of quality, management by facts.
• Investigate customer complaints including associated actions including CAPA, deviations, and complaint responses.

Credentials/Experience

• Qualification Requirements: Bachelor’s Degree in Engineer or related field. Or a minimum of 4 years’ experience within the Medical Device Industry, and Certification (ASQ CQE or CMQ/QE) Experience/Educational/Training Preferred ASQ CQE or CMQ/QE preferred2 years’ experience in quality within medical device manufacturing industry preferredISO 13485, FDA 820 and customer interaction experience preferred
• Knowledge, Skills, And Abilities: Manufacturing operations - forging and/or machining.Measuring devices.Quality Systems.Regulations - FDA, GMP and ISO.Blueprint reading.GD&T.Metrology.Problem solving and 8D.Math skills (algebra, trigonometry) skills.Microsoft office (Word, Excel, Outlook, PowerPoint).Minitab.