Quality Engineer II — Medical Device QA & Process

Litchfield Chamber of Commerce; Northern (KY); Hybrid; USD 75,000 - 136,000; Full time

Benefits offered by this job

Continuing education opportunities

Job summary

Cretex Medical is a leading contract manufacturer serving the medical device industry, offering precision components and assemblies. The Quality Engineer will define, implement, and improve quality practices and provide technical guidance and measurement support across manufacturing operations.

Open to Level II or III based on experience, the role emphasizes QA processes, audits, data analysis, and collaboration with sales, engineering, and quality teams to ensure regulatory compliance and

Qualifications

• Quality systems knowledge and regulatory awareness.
• Blueprint reading and GD&T proficiency.
• Data analysis and data integrity.
• Operate inspection equipment and interpret results.
• DOE and Capability studies statistics experience.
• Proficient in Minitab and related tools.
• Strong verbal and written communication.
• Detail orientation and organization.

Responsibilities

• Provide QA support for manufacturing and projects.
• Develop inspection requirements; facilitate PFMEAs; resolve material discrepancies; create control and inspection plans.
• Analyze data to identify improvements.
• Act as QA interface with production addressing customer complaints with root cause analysis and corrective/preventive actions.
• Lead/participate in projects delivering quality recommendations.
• Support process, equipment, and metrology validation.
• Create protocols and analyze data.
• Ensure inspection plans meet customer requirements and quality systems.

Skills

Quality engineering

Data analysis

DOE

GDT

Measurement systems

Communication

Audits

Inspection equipment

Education

Bachelor's degree in Mechanical/Industrial Engineering (or related)

Tools

Minitab

Job description

Cretex Medical is a leading contract manufacturer serving the medical device industry, offering precision components and assemblies. The Quality Engineer will define, implement, and improve quality practices and provide technical guidance and measurement support across manufacturing operations.

Open to Level II or III based on experience, the role emphasizes QA processes, audits, data analysis, and collaboration with sales, engineering, and quality teams to ensure regulatory compliance and