Staff Quality Engineer (Fishers)

Join our team in Fishers, Indiana! TOMZ Corporation, a leader in manufacturing of devices and components for major medical device companies, is looking for a highly motivated Staff Quality Engineer to join our organization. TOMZ offers competitive compensation and excellent benefits, including 401k, health / dental, vision, and paid time off. TOMZ maintains a modern, clean, and safe facility with state-of-the-art equipment and dedication to continuous process improvement. TOMZ is registered with the FDA as a Class 2 and Class 3 Medical Device Manufacturer and certified to ISO 13485.

Summary of Position :

This position will be responsible for the activities associated with Quality Engineering, Control and Assurance continuation development support for continuous improvement of manufacturing processes.

Essential Functions :

• Author and execute Manufacturing Quality Plans, Control Plans and Master Validation Plans.
• Leads on strategic initiatives to improve Quality Processes and Systems.
• Owns the development and / or update of Risk Management files in cooperation with cross-functional engineering teams, operations and customers.
• Supports the procurement and qualification of capital equipment.
• Operates and programs advanced measurement equipment including Vision Systems and CMMs.
• Authors Inspection Plans and defines process controls. Defines Test Method.
• Subject Matter expertise of precision measuring instruments and their application, including but not limited to, calipers, micrometers, depth gages, indicators, and plug and thread Go / No Go gages.
• Execution and evaluation of Test Method Validations.
• Creation of production visual standards and standardized acceptance criteria for TOMZs manufacturing processes.
• Initiate and / or consult in the development and / or update of Risk Management documentation in cooperation with cross-functional engineering teams per project requirements.
• Performs process qualifications, analyzes data and initiates corrections or corrective actions as required
• Support and enforce Quality Best Practices and GDP / GMP continuous improvement efforts.
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, resolving quality issues through the CAPA process.
• Defines and Measures KPIs for New Product Introduction.
• Interfaces with the customer and meets all defined deliverables.
• Support the tracking and reporting of inspection data, including but not limited to rejection rates, defect modes and process trends across customers / product families.
• Generate ECOs for the release of Quality Engineering documentation.

Education / Experience

Qualifications

Preferred skills