Staff Quality Engineer

Job Description

Job Description

TOMZ Corporation, a leader in manufacturing of devices and components for major medical device companies, is looking for a Senior 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 Medical Device Manufacturer and is 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 :

• Must be knowledgeable of, and adhere to, the TOMZ Quality Management System.
• 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.

QUALIFICATIONS :

Education / Experience

Qualifications

Preferred skills