Associate Quality Engineer

Summary of Position: Reporting to the Quality Manager this position will be responsible for the activities associated with quality engineering in a medical device manufacturing environment. This includes but is not limited to assessing process risk and implementing appropriate control mechanisms, corrective and preventative action, and creating and refining test methods.Essential Functions:

• Operates and programs advanced measurement equipment including Vision Systems and CMMs.
• Authors Inspection Plans and defines process controls.
• Collaborates and defines Test Method.
• Knowledge of precision measuring instruments and their application, including but not limited to, calipers, micrometers, depth gages, indicators, and plug and thread Go gages and No-Go gages.
• Execution and evaluation of Test Method Validations.
• Support the creation of production visual standards and standardized acceptance criteria for TOMZ’s manufacturing processes.
• Initiate and consult in the development and update of Risk Management documentation in cooperation with cross-functional engineering teams per project requirements.
• Collaborates to develop Process Master Validation Plans.
• 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.
• Champion First Article Inspections.
• 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, and resolving quality issues through the CAPA process.
• Support the tracking and reporting of inspection data, including but not limited to rejection rates, defect modes and process trends across customers and product families.
• Generate ECOs for the release of Quality Engineering documentation.
• Adhere to the TOMZ Quality Management System.
• Perform other duties as assigned.

Qualifications:

• Demonstrated self-starter with ability to work in a fast-paced environment.
• Competency with Microsoft Office (i.e. Outlook, Word, Excel, and PowerPoint)
• Strong verbal and written English language communication skills.
• Basic understanding of statistical techniques and sampling strategies

Education:

• Bachelor’s or higher degree in Engineering, Manufacturing, or Business discipline or equivalent of directly transferable industry work experience.

Experience:

• Minimum of 0-2 years’ experience in a regulated manufacturing environment.
• Prior relevant internship experience preferred.

Preferred Skills:

• ASQ-CQT, CQE or CRE preferred.
• Certification in GD&T preferred
• Certifications in DMIS programming preferred
• Class I, II and/or III Medical Device manufacturing experience.
• Regulated manufacturing industry experience (e.g. Aerospace, Defense, Pharmaceutical, etc.)

Travel Requirements:

• Travel outside the workplace is required for up to 15% of the year.
• Travel may include multiple overnight stays and may occasionally require weekend commitments.

Physical Demands:

• Ability to bend, stoop, squat, kneel, and lift up to 30 pounds. Team lift or mechanical assistance required for objects over 30 pounds.
• Ability to sit for prolonged periods.
• Exposure to oil, grease, occupational noise, cleaning solvents, dust, metal particles, sparks, coolant, and sharp-edged materials. Personal protective equipment (PPE) such as safety glasses, dust masks, ear plugs, cut-resistant or chemical-resistant gloves, and engineering controls may be required.
• Perform keyboard entries with frequent operation of a computer.

TOMZ Manufacturing Corp