Quality Systems Engineer — GMP/CQV & CI

Innovative Refrigeration Systems, Inc.; Lyndhurst (VA); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

401(k) match up to 15%

Medical insurance

Dental and vision insurance

Disability insurance (short/long term)

Life insurance

Paid time off

Career development opportunities

Job summary

Innovative Refrigeration Systems, Inc. is seeking a QMS Engineer to manage and continuously improve the company’s Quality Management System.

You will partner across Engineering, Manufacturing, Procurement, and Project Management to standardize quality processes, support validation activities, and drive CAPA and change-control initiatives. Responsibilities include developing QA procedures, performing internal audits, and supporting IQ/OQ/PQ documentation.

Qualifications

• Five or more years of experience in Quality Engineering, Manufacturing Engineering, or Quality Systems.
• Experience supporting Quality Management Systems, CAPA, change control, deviation investigations, quality audits, and continuous improvement initiatives.
• Working knowledge of GMP principles, validation documentation, and CQV methodologies preferred.
• Strong understanding of manufacturing processes, engineering drawings, BOMs, specifications, and document control practices.
• Experience with ECNs, ERP/MRP systems, and quality methodologies including SPC, FMEA, 5 Whys, Kaizen, and risk-based decision making.
• Excellent analytical, organizational, documentation, and communication skills.
• Ability to manage multiple priorities in a fast-paced manufacturing environment.
• Ability to work in both office and manufacturing settings and occasionally lift up to 25 pounds.

Responsibilities

• Maintain, improve, and ensure compliance with the Quality Management System (QMS).
• Develop, document, execute, and validate quality procedures, work instructions, inspection plans, FAT protocols, and CQV quality documentation.
• Support qualification and validation activities, including IQ/OQ/PQ documentation and protocol execution where applicable.
• Develop, implement, and verify the effectiveness of CAPA actions.
• Manage ECNs and assess quality impacts of changes through change control.
• Coordinate internal quality audits and support supplier and customer audits.
• Support new product introductions, manufacturing readiness, risk assessments, and process validation activities.
• Partner with cross-functional teams to design quality into manufacturing processes and products.
• Coordinate quality system training and provide technical guidance to manufacturing and quality personnel.

Skills

Quality Engineering

Manufacturing Engineering

Quality Systems

CAPA

Change control

Documentation

Education

Bachelor's degree in Engineering, Manufacturing, Quality, Life Sciences, or related field

Tools

ERP/MRP systems

SPC

FMEA

5 Whys

Kaizen

CQV

Job description

Innovative Refrigeration Systems, Inc. is seeking a QMS Engineer to manage and continuously improve the company’s Quality Management System.

You will partner across Engineering, Manufacturing, Procurement, and Project Management to standardize quality processes, support validation activities, and drive CAPA and change-control initiatives. Responsibilities include developing QA procedures, performing internal audits, and supporting IQ/OQ/PQ documentation.