Quality Management Systems Engineer

Innovative Refrigeration Systems, Inc.; Lyndhurst (VA); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

401(k) match up to 15%

Medical insurance coverage (75%)

Dental and vision insurance

Disability insurance

Life insurance

Paid time off

Job summary

Innovative Refrigeration Systems, Inc. seeks a QMS Engineer to maintain and improve the Quality Management System across engineering, manufacturing and service. You will document procedures, support IQ/OQ/PQ validation, and drive CAPA effectiveness to ensure GMP-aligned processes.

Join a cross-functional team focusing on continuous improvement, supplier and customer audits, and robust change control within a fast-paced industrial setting.

Qualifications

• Bachelor's degree in Engineering, Manufacturing, Quality, Life Sciences, or related field preferred; equivalent experience considered.
• Five+ years of experience in Quality/Manufacturing Engineering or Quality Systems.
• Experience with GMP, validation documentation, and CQV methodologies.

Responsibilities

• Maintain, improve, and ensure compliance with the QMS.
• Develop, document, execute, and validate quality procedures and inspection plans.
• Support qualification and validation activities (IQ/OQ/PQ) and protocol execution.
• Develop, implement, and verify CAPA effectiveness.
• Manage ECNs and assess quality impacts of changes.
• Coordinate quality documentation and audits; support supplier/customer audits.

Skills

Quality engineering

CAPA

Change control

Deviation investigations

Quality audits

GMP

CQV

ECNs

ERP/MRP

SPC

FMEA

5 Whys

Kaizen

Risk-based decision making

Document control

Analytical skills

Communication skills

Education

Bachelor's degree in Engineering / Manufacturing / Quality / Life Sciences

Tools

Epicor ERP

Job description

Innovative Refrigeration Systems, Inc. is the leading provider of industrial refrigeration and process cooling solutions, delivering custom engineered systems utilizing natural refrigerants such as ammonia and CO₂. Through a fully integrated approach encompassing engineering, manufacturing, construction, commissioning, nationwide service, and advanced aftermarket solutions, Innovative supports customers across the food and beverage, cold storage, pharmaceutical, industrial manufacturing, and mission-critical infrastructure markets throughout North America and around the world.

Unlike traditional engineering firms, contractors, or equipment suppliers, Innovative performs engineering, manufacturing, construction, commissioning, service, and ongoing customer support entirely in-house. This integrated model provides employees with the opportunity to support projects throughout the complete lifecycle, from concept and design through manufacturing, installation, startup, operation, optimization, modernization, and long-term system support.

Job Role

The QMS Engineer manages, maintains, and continuously improves Innovative's Quality Management System (QMS), ensuring products consistently meet quality, engineering, regulatory, and customer requirements. This role partners with Engineering, Manufacturing, Production, Procurement, and Project Management to standardize quality systems, ensure process compliance, support validation activities, investigate nonconformances, and drive continuous improvement throughout the organization.

Key Duties

• Maintain, improve, and ensure compliance with the Quality Management System (QMS).
• Develop, document, execute, and validate quality procedures, work instructions, inspection plans, Factory Acceptance Testing (FAT) protocols, and quality documentation in support of GMP and Commissioning, Qualification, and Validation (CQV) requirements.
• Support qualification and validation activities, including IQ/OQ/PQ documentation and protocol execution where applicable.
• Develop, implement, and verify the effectiveness of Corrective and Preventive Actions (CAPA).
• Manage Engineering Change Notices (ECNs) and assess quality impacts of manufacturing and process changes through change control.
• Coordinate PCIs, SNCRs, DRs, KQPs, and other quality documentation.
• Plan and perform internal quality audits and support supplier and customer audits as required.
• Support new product introductions, manufacturing readiness, risk assessments, and process validation activities.
• Partner with cross-functional teams to ensure quality is designed into manufacturing processes and products.
• Coordinate quality system training and provide technical guidance to manufacturing and quality personnel.

Requirements

• Bachelor's degree in Engineering, Manufacturing, Quality, Life Sciences, or related field preferred; equivalent experience considered.
• 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.

Preferred Qualifications

• Experience in GMP-regulated manufacturing, pharmaceutical, biotechnology, food, medical device, or other highly regulated industries.
• Experience supporting equipment qualification, process validation, Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), IQ/OQ/PQ, or Commissioning, Qualification, and Validation (CQV).
• Experience with engineer-to-order (ETO), low-volume/high-mix manufacturing.
• Experience with ISO 9001 and/or regulated quality systems.
• ASQ Certified Quality Engineer (CQE), ISO Lead Auditor, Lean Six Sigma, or similar certification.
• Experience with industrial refrigeration equipment, pressure vessels, piping systems, structural fabrication, or custom-engineered products.
• Experience with Epicor or similar ERP systems.

Benefits

In addition to a competitive base salary, we provide a comprehensive and employee-focused benefits package designed to support your financial security, health, and work-life balance:

• Generous retirement plan with a dollar-for-dollar 401(k) match up to 15%
• 401(k) student loan repayment match up to 15%
• Medical insurance with 75% of employee and family premiums covered by the company
• Dental and vision insurance options
• Optional supplemental insurance coverage
• Short-term and long-term disability insurance
• Accidental death and dismemberment (AD&DD) coverage
• Company-paid life insurance
• Weekly pay
• Competitive paid vacation and holiday time
• Paid sick leave, bereavement leave, and jury duty leave
• Employee referral bonus program
• Opportunities for career advancement, professional development, training, and apprenticeship programs
• Access to employee discounts on cell phone plans, vehicle rentals, and other eligible services