About the position
TOMZ Corporation is looking to hire a highly motivated and driven Senior Process Quality Engineer to join our organization. A leader in manufacturing of devices and components for major medical device companies, TOMZ offers competitive compensation and excellent benefits. Those include 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 is certified to ISO 13485. This position will be responsible for improving safety, quality, delivery, productivity and cost by proactively improving the processes of the company to reduce variation prevent nonconformities and drive Quality to the Source. The Process Quality Engineer will work to reduce the Cost of Poor Quality through sound scientific principles to lead the transition from Quality Control to Quality Assurance. This includes but is not limited to Process Analytical Technology (PAT), Precontrol, SPC, Human Factors Engineering, Process Validation, User Validation, Certified Operator Programs, Standard Work, Advance Metrology, Poka-Yoke, Jidoka, as well as using statistical techniques for identifying problems and resolving them using CAPA, Six Sigma and the Toyota Kata PDCA approach.
Responsibilities
- Must be knowledgeable of, and adhere to, the TOMZ Quality Management System.
- Author and execute Manufacturing Quality Plans, Control Plans and Master Validation Plans to support New Product Introduction.
- Completes and compiles necessary documentation related to Quality Inspection standards.
- Support Quality Best Practices and GDP/GMP continuous improvement efforts.
- Utilize and navigate ERP and QMS systems to ensure inspection and traceability activities are properly documented and controlled, as needed.
- Collaborate with team members to achieve company, business unit and team goals.
- Proactively identify areas for improvement and implement plans to achieve and realize those improvements.
- Provide interpretation and manage external, internal, customer and supplier quality issues.
- 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.
- Provides hands on direction for executing Incoming, In-Process and Final Product Inspection plans.
- Support Gage calibration review, management, execution and evaluation.
- 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 key process indicators.
- 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.
- Other duties and responsibilities as assigned.
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 5+ years of manufacturing quality experience including advanced metrology experience including CMM and/or Vision System programming. (10+years of experience in Quality Engineering or similar discipline will be considered in lieu of a degree)
- Ability to travel up to 5%.
- 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 problem solving and statistical techniques, GD&T, process validation, lean principles 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. (ex: 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).
Benefits
- 401k
- health/dental
- vision
- paid time off
