We are seeking a detail-oriented and experiencedQuality Engineerto join our team. In this role, you will play a critical part in ensuring that our products meet all design, quality, and regulatory standards from concept through production. Youll collaborate across departments, communicate with customers and vendors, and drive continuous improvement throughout the quality lifecycle.

Key Responsibilities: Participate in product design and development, ensuring adherence to all specifications and requirements. Review and interpret technical drawings, focusing on tolerances, inspections, and quality compliance. Manage gage calibration and ordering to ensure availability for production needs. Lead and execute machine and process validations; plan, analyze, and report statistical data related to manufacturing processes. Interpret and implement customer validation plans and requirements. Manage and communicate changes to internal and external documentation. Investigate customer complaints and non-conformances; lead containment and corrective action processes. Oversee material certifications and ensure compliance with approved specifications. Assist in the development of testing and inspection methods and tools. Generate and manage Engineering Change Orders (ECOs). Create and track non-conforming parts reports; support material disposition decisions. Collaborate with suppliers, customers, and internal teams to resolve quality-related issues. Maintain accurate documentation including inspection records and work travelers. Manage supplier quality files and performance tracking. Coordinate or deliver quality-related training to staff. Work toward quality objectives and cost efficiency by improving inspection processes and eliminating production bottlenecks.

Qualifications: Bachelors degree in Engineering or a related field. Minimum of 5 years of experience in quality engineering (or a combination of relevant education and experience). Strong understanding of engineering principles, GD&T, and blueprint reading. Proficient with precision measuring tools (e.g., calipers, micrometers, depth gauges, indicators, Go/No Go gauges). Knowledge of ISO 13485 and FDA 21 CFR 820 requirements. Experience with software tools such as Microsoft Office, SolidWorks, Adobe PDF, ERP systems, and metrology software. Strong mathematical skills including geometry, algebra, and metric conversions. Excellent organizational and prioritization skills. Ability to work independently and manage multiple tasks effectively. Strong communication skills, both written and verbal. Willingness to adapt to new technologies and continuous improvement initiatives.