Staff Quality Engineer

TOMZ Corporation•Fishers, IN

68d

About The 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.

Requirements

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)
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.

Nice To Haves

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).

Responsibilities

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.