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Tecomet Quality Engineer in Wilmington, Massachusetts

The Quality Engineer ensures the quality-related requirements from Tecomet?s customers are communicated clearly and concisely to manufacturing, engineering, and the shop floor. The Quality Engineer works to reduce overall manufacturing quality costs to increase profitability and meet customer requirements while effectively teaching quality sciences to team members. 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. Essential Duties and Responsibilities: Maintain applicable quality systems, environmental, and FDA requirements/certifications. Work with team members and support manufacturing/operations to solve quality, cost and schedule issues. Proficient in full and proper Geometric Dimensioning & Tolerancing (GD&T) application, and blueprint reading. Determine/improve inspection methods/instructions and incorporate them into the manufacturing processes and Inspection Plans. Review customer orders for overall quality requirements. Prepare and maintain FMEA?s, control plans, quality plans, and PPAP. Coordinate process validations and reduce dependence on inspection. Generate applicable quality metric reports; cost of quality, management by facts. Support the MRB and RMA processes. Investigate customer complaints including associated actions including CAPA, deviations, and complaint responses. Demonstrate a working knowledge of standard manufacturing operations, FDA and ISO regulations, Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP) requirements, and standard problem solving techniques. Consult with manufacturing engineers in resolving quality-related issues. Works with Engineering to conceptualize and develop gauging. Applies basic statistical and Six Sigma concepts and techniques. Maintain knowledge of all procedures, changes to specifications and new regulations related to areas of responsibility. Conduct internal audits and support external audits. Other duties/projects as assigned by the Quality Management. Qualification Requirements Educational/Training Requirement: Bachelors? degree with engineering focus preferred or equivalent combination of education and experience. Experience: 3 plus years? experience in quality within medical device manufacturing or Automotive industry, preferred. ISO 13485, CAPA, Validations and customer interaction experience required. Licenses/Certifications: ASQ CQE Certification Preferred Six Sigma Black belt certification, preferred Knowledge, Skills, and Abilities: Manufacturing Operations machining and/or forging Quality systems Regulations FDA, GMP and ISO Regulations Metrology Blue Print Reading / GD&T Problem solving and 8D Customer-focused environment Must be able to read and interpret engineering drawings, ANSI-Y-14.5 dimensioning and tolerancing Knowledge of ANSI-Z1.4 and 1.9 lot sampling PC Literacy, windows operations system, Microsoft office (work, excel, outlook, PowerPoint)