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 TOMZ’s 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 KPI’s 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

• Bachelor's or higher degree in Engineering, Manufacturing, or Business discipline or equivalent of directly transferable industry work experience.
• Minimum of 0-4 years’ experience in a regulated manufacturing environment.
• Engineering degree and 7+ years of manufacturing quality experience including advanced metrology experience including CMM and/or Vision System programming. (12+ years of experience in Quality Engineering or similar discipline will be considered in lieu of a degree)

Qualifications

• Ability to travel up to 20%.
• Demonstrated self-starter with ability to work in a fast-paced environment.
• Competency with Microsoft Office (Visio, Project, Outlook, Word, Excel, and PowerPoint)
• Strong verbal and technical writing capabilities (English language).
• Expertise is statistical techniques, GD&T, process validation, and Metrology.
• Demonstrated ability to work in and lead teams through large scale projects.

Preferred skills

• ASQ CQE or CRE.
• Expertise in 3D modeling Solid Works, Unigraphics, Mastercam, Solid Edge, etc.
• Six Sigma Green or Black belt.
• Certifications in DMIS programming preferred
• Regulated manufacturing industry experience preferably Class I, II and/or III Medical Device manufacturing experience. (exp: Aerospace, Defense, Pharmaceutical, etc.)
• Knowledge and experience with external standards: ISO 9000/9001, ISO 13485, and 21CFR 820, EU MDR, especially pertaining to product development, design controls, good manufacturing practices, supplier qualification, auditing, quality control (GD&T, Nonconforming Materials, MRB), Corrective and Preventive Actions, and customer complaints).