Quality Engineer

Quality Engineer

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.
• Support the Material Review Board and Return Material Authorization (RMA) processes.
• Work with team members and support manufacturing/operations to solve quality, cost and schedule issues.
• Prepare Failure Mode and Effect Analysis (FMEA) documents, control plans, quality plans, Production Part Approval Process(PPAP).
• Coordinate process validations and reduce dependence on inspection.
• Generating applicable quality metric reports; cost of quality, management by facts. 
• Investigate customer complaints including associated actions including Corrective and Preventative Action (CAPA), deviations, and complaint responses.
• Special projects as assigned by quality management.
• Must demonstrate a working knowledge of standard manufacturing operations, FDA and ISO regulations.
• Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP) requirements.
• Standard problem-solving techniques.  
• Applies statistical and Six Sigma concepts and techniques.  
• Works with Internal and External Customers.
• Participates in audits and inspections.

Qualification Requirements

Credentials/Experience:

• 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 preferred
• 2 years’ experience in quality within medical device manufacturing industry preferred
• ISO 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.
• Geometric Dimensioning and Tolerancing (GD&T)
• Metrology.
• Problem solving and 8D.
• Math skills (algebra, trigonometry) skills.
• Microsoft office (Word, Excel, Outlook, PowerPoint).
• Minitab.