TOMZ Corporation, a leader in manufacturing of devices and components for major medical device companies, is looking for a driven and highly motivated Quality Engineering Technician 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 is certified to ISO 13485.
Summary of Position
This position will be responsible for the activities associated with Inspection/Test Method development and improvement. This role will be expected to collaborate with Quality Engineering to support sustaining manufacturing and product development.
Essential Functions
- Must be knowledgeable of, and adhere to, the TOMZ Quality Management System.
- Programming automated metrology systems such as CMM’s and Vision Systems.
- Author Quality Inspection documentation such as Inspection Plans, with appropriate inspection methods and frequency rationales.
- Support the creation of production visual standards and standardized acceptance criteria for TOMZ’s manufacturing processes.
- Support the generation and maintenance of Process Control Plans.
- Initiate and/or consult in the development and/or update of Risk Management documentation in cooperation with cross-functional engineering teams per project requirements.
- Contribute to test method development and selection.
- Knowledge 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.
- Assist in the execution and/or data collection of Test Method Validations and Gage R&R’s.
- Review standard inspection labor times for first article, first piece inspection, in-process and final inspection.
- Collaborate with Quality Engineering to identify and implement inspection cycle time reduction continuous improvement opportunities.
- Support the tracking and reporting of inspection data, including but not limited to rejection rates, defect modes and process trends across customers/product families.
- Support the generation of “redlines” for updates to Quality Engineering and Inspection documentation.
- Generate ECOs for the release of Quality Engineering documentation.
- Other duties and responsibilities as assigned.
Qualifications:
Education
- High school diploma, GED, or equivalent directly transferrable work experience (Manufacturing or Engineering discipline preferred).
Experience
- Minimum of 2-5 years’ experience in a regulated manufacturing environment.
Qualifications
- Regulated manufacturing industry experience (e.g. Aerospace, Defense, Pharmaceutical, etc.)
- Knowledge of and experience with GMP/ISO standards.
- Knowledge of and the ability to read geometric dimensions and tolerances.
- Previous experience programming CMM’s and/or vision systems.
- Strong verbal and written English language communication skills.
- Competency with Microsoft Office (i.e. Outlook, Word, Excel, and PowerPoint).
- “Hands-on” self-starter with ability to work both independently and as part of a team.
- Ability to work with a variety of functional areas, including R&D, Manufacturing, and QA as required accomplishing results with minimal guidance.
- CMM operation, setup, and programing highly preferred.
Preferred Skills
- Strong verbal and written English language communication skills.
- Competency with Microsoft Office (i.e. Outlook, Word, Excel, and PowerPoint
Physical Demands
While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls. The employee is occasionally required to stand, and/or walk. The employee must occasionally lift and/or move up to 10 pounds while moving files or small packages. The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.
