Staff Quality Engineer Job at TOMZ Corporation, Fishers, IN

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  • TOMZ Corporation
  • Fishers, IN

Job Description

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).

Job Tags

Work experience placement, Work at office,

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