Manufacturing Process Engineer II — Validation & Development

Quality Consulting Group, LLC; Northern (KY); On-site; USD 80,000 - 110,000; Full time

Job summary

Quality Consulting Group, LLC is seeking a talented Process Engineer to join our team, contributing in a world-class manufacturing environment across Puerto Rico and the USA. You will drive process development, equipment IQ/OQ/PQ, and MES-related activities to ensure product quality and regulatory compliance.

The role emphasizes documentation, DOE with MINITAB, and change control of medical devices, with a first shift in a manufacturing setting. Equal opportunity employer.

Qualifications

• Bachelor’s degree in Engineering.
• 3+ years of relevant experience.
• Process Development and documentation.
• Equipment IQ/OQ/PQ and/or process validation experience.
• DOE experience preferred (with MINITAB).
• CSV/software validation and change control of Medical Devices.
• MES system experience.
• Shift: 1st shift.

Responsibilities

• Working on the introduction on a new product and/or components.
• Designs manufacturing processes, procedures and production layouts for assemblies, equipment installation, processing, machining and material handling.
• Designs arrangement of machines within plant facilities to ensure most efficient and productive layout.
• Designs sequence of operations and specifies procedures for the fabrication of tools and equipment and other functions that affect product performance.
• Adapts machine or equipment design to factory and production conditions.
• May incorporate inspection and test requirements into the production plan.
• Inspects performance of machinery, equipment, and tools to verify their efficiency, and investigates and initiates corrective action of problems and deficiencies to ensure product quality.
• Develops manufacturing processes that are applicable to statistical process control and may develop those techniques.

Skills

Process Development

SOP Development

Equipment validation

OQ/PQ/Validation

DOE (with MINITAB)

CSV validation

Change control

MES system

Line Support

Education

Bachelor’s degree in Engineering

3+ years of relevant experience

Tools

MINITAB

Job description

Quality Consulting Group, LLC is seeking a talented Process Engineer to join our team, contributing in a world-class manufacturing environment across Puerto Rico and the USA. You will drive process development, equipment IQ/OQ/PQ, and MES-related activities to ensure product quality and regulatory compliance.

The role emphasizes documentation, DOE with MINITAB, and change control of medical devices, with a first shift in a manufacturing setting. Equal opportunity employer.