Job Description

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.

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