Quality Engineer

G&H Orthodontics, Inc; United States; On-site; USD 70,000 - 90,000; Full time

Job summary

G&H Orthodontics, Inc is seeking a versatile Quality Engineer to collaborate with operations and engineering to reduce scrap and improve processes. You will investigate quality issues, identify root causes using data analysis, and support IQ/OQ/PQ validations.

Responsibilities include leading quality projects, trending indicators for reviews, and supporting documentation and SOP development. Strong communication and problem-solving skills are essential in a fast-paced manufacturing environment.

Qualifications

• Bachelor's degree in Engineering or related field.
• 1–2 years manufacturing experience, preferably in medical devices.
• Knowledge of Statistical Process Controls.
• Understanding of drawings, specifications, and blueprints.

Responsibilities

• Ensure product and process validations are completed.
• Perform discrepant material disposition with guidance.
• Recommend inspection plans, test methods, and SOPs.
• Conduct statistical analysis and root-cause analysis.

Skills

Problem solving

Analytical skills

Communication

Time management

Attention to detail

Decision making

Interpersonal skills

Written and oral communication

Project management

Teamwork

Education

Bachelor’s degree in Engineering

Tools

Calipers

Micrometers

Tensile strength testers

Job description

G&H Orthodontics, located in Franklin Indiana, is a worldwide supplier and manufacturer of orthodontic supplies. As a company G&H believes in providing our customers with the best in class service.We are currently looking for a versatile and driven Quality Engineer to join our team.

JOB SUMMARY:

The Quality Engineer will work closely with operations and engineering to reduce scrap and drive continuous improvement activities to reduce customer complaints and lower the response time. This position will investigate internal and external quality issues and identify root cause, using data analysis, data trending and periodic reporting. This position will perform product and process validations (IQ, OQ, PQ).

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Ensure product and process validations are completed.
• Perform discrepant material disposition with guidance.
• Recommend inspection plans, test methods, and standard operating procedures.
• Conduct sample size determination, statistical analysis, root cause analysis and applicable training.
• Actively contribute to various manufacturing projects such as process development, cost reduction and quality improvement initiatives.
• Collect and trend quality indicators for monthly and quarterly reviews.
• Support documentation development including writing specifications for manufacturing or scientific test results.
• Support in management, implementation, and documentation of IQ, OP, PQ.
• Participate in cross-functional teams in continuous quality improvement projects.
• Participate in the Internal Audit process and assist in addressing observations.
• Determines quality improvement parameters by identifying statistical methods relevant to manufacturing processes.
• Analyzes data by completing hypothesis, normal distribution, and process capability analysis tests.
• Interface with customers and coordinate internal efforts to improve processes.
• Lead process activity as it relates to customer or internal quality. Ensure timely resolution of quality problems and implement long-term solutions to prevent re-occurrence of problem.

Qualifications:

• Must have excellent problem solving skills.
• Strong analytical skills with an ability to use scientific knowledge and statistical methods to identify issues and assess acceptability of system and process performance.
• Strong communication, organization and time management skills are necessary.
• Ability to prioritize work per business needs in a fast-paced environment.
• High degree of accuracy and attention to details.
• Ability to make decisions based on expertise and customer/business requirements.
• Ability to perform essential functions and responsibilities with little to no supervision.
• Excellent interpersonal skills, teamwork oriented with a positive attitude.
• Excellent written and oral communication, technical writing and editing skills.
• Proficient in the use of Microsoft Office (Word, Excel, PowerPoint, etc.) and Adobe.
• Excellent research and analytical skills

Training, Education & Experience:

• Bachelor’s degree in Engineering field (desired).
• 1 - 2 years related experience in manufacturing (prefer Medical Devices Industry).
• Demonstrated knowledge and understanding of Statistical Process Controls
• Basic understanding of engineering and mathematics principles.
• Understand interpretation of drawings, specifications, blueprints, and etc.
• Able to use inspection and measuring instruments such as calipers, micrometers, tensile strength testers (e.g. Instron), etc.
• Highly motivated, detail-oriented, eager to learn.
• Strong analytical, problem solving and teamwork skills are required.
• Able to follow instructions in all formats: written, verbal, and electronic.
• Excellent time management, prioritization abilities, and strong project management skills
• Excellent interpersonal, communication, and presentation skills