QMS Engineer: Drive GMP Compliance and Continuous Improvement

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%

Life insurance

Health insurance

Job summary

Innovative Refrigeration Systems, Inc. seeks a QMS Engineer to lead and improve the Quality Management System across engineering, manufacturing, and project teams.

You will standardize quality processes, support validation activities, perform CAPA investigations, and drive continuous improvement through the product lifecycle. The role collaborates with Engineering, Production, Procurement, and Project Management to ensure compliance and robust quality documentation, including FAT, IQ/OQ/PQ, and

Qualifications

• 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, 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.

Responsibilities

• Maintain the Quality Management System (QMS) and drive compliance across the organization.
• Develop, document, execute, and validate quality procedures, work instructions, inspection plans, FAT protocols, and CQV documentation.
• Support qualification and validation activities, including IQ/OQ/PQ documentation and protocol execution where applicable.
• Develop, implement, and verify effectiveness of CAPA actions and corrective actions.
• Manage Engineering Change Notices (ECNs) and assess quality impacts of manufacturing changes via change control.
• Coordinate quality documentation including PCIs, SNCRs, DRs, KQPs, etc.
• Plan and perform 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 guidance to manufacturing and quality personnel.

Skills

Quality engineering

Manufacturing engineering

Documentation

Analytical skills

Multitasking

Education

Bachelor's degree in Engineering

Tools

ERP/MRP systems

ECNs

FMEA

CQV methods

Job description

Innovative Refrigeration Systems, Inc. seeks a QMS Engineer to lead and improve the Quality Management System across engineering, manufacturing, and project teams.

You will standardize quality processes, support validation activities, perform CAPA investigations, and drive continuous improvement through the product lifecycle. The role collaborates with Engineering, Production, Procurement, and Project Management to ensure compliance and robust quality documentation, including FAT, IQ/OQ/PQ, and