обновлено 12 дней назад
Quality Management Systems Engineer (Manufacturing)
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Quality Management Systems Engineer (Manufacturing) (QMS/GMP): Maintaining and improving quality management systems for custom-engineered industrial refrigeration and process cooling equipment with an accent on validation, CAPA, change control, and manufacturing compliance. Focus on executing IQ/OQ/PQ and CQV documentation, conducting audits, investigating nonconformances, and driving continuous improvement across engineering and manufacturing.
Location: Lyndhurst, Virginia, United States. Work is performed in both office and manufacturing settings.
Salary: Dependent on experience
Company
provides custom-engineered industrial refrigeration and process cooling solutions using natural refrigerants such as ammonia and CO₂, with engineering, manufacturing, construction, commissioning, service, and aftermarket support performed in-house.
What you will do
- Maintain, improve, and ensure compliance with the Quality Management System.
- Develop and validate quality procedures, work instructions, inspection plans, FAT protocols, and quality documentation.
- Support qualification and validation activities, including IQ/OQ/PQ and CQV documentation and protocol execution.
- Implement CAPA, manage Engineering Change Notices, and assess quality impacts of manufacturing and process changes.
- Coordinate quality documentation, internal audits, supplier and customer audits, product introductions, risk assessments, and manufacturing readiness.
- Partner with engineering, manufacturing, procurement, production, and project management teams to embed quality into processes and products and provide quality-system training.
Requirements
- Bachelor’s degree in engineering, manufacturing, quality, life sciences, or a related field preferred; equivalent experience may be considered.
- At least five years of experience in quality engineering, manufacturing engineering, or quality systems.
- Experience with quality management systems, CAPA, change control, deviation investigations, quality audits, and continuous improvement.
- Working knowledge of GMP principles, validation documentation, CQV methodologies, manufacturing processes, engineering drawings, BOMs, specifications, and document control.
- Experience with ECNs, ERP/MRP systems, SPC, FMEA, 5 Whys, Kaizen, and risk-based decision-making.
- Ability to manage multiple priorities in a fast-paced manufacturing environment and occasionally lift up to 25 pounds.
Nice to have
- Experience in GMP-regulated manufacturing, pharmaceutical, biotechnology, food, medical device, or other highly regulated industries.
- Experience with equipment qualification, process validation, FAT, SAT, IQ/OQ/PQ, or CQV.
- Experience with engineer-to-order, low-volume/high-mix manufacturing, ISO 9001, or regulated quality systems.
- ASQ Certified Quality Engineer, ISO Lead Auditor, Lean Six Sigma, or similar certification.
- Experience with industrial refrigeration equipment, pressure vessels, piping systems, structural fabrication, custom-engineered products, Epicor, or similar ERP systems.
Culture & Benefits
- Employee-focused benefits package supporting financial security, health, and work-life balance.
- Dollar-for-dollar 401(k) match and student loan repayment match, each up to 15%.
- Medical, dental, vision, supplemental, disability, AD&D, and company-paid life insurance coverage.
- Weekly pay, paid vacation and holidays, sick leave, bereavement leave, and jury duty leave.
- Professional development, training, apprenticeship programs, career advancement opportunities, and employee discounts.
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