Validation Engineer - job 1 of 2
Company Description
QRC Group, LLC is a firm dedicated to offer services to the Pharmaceutical, Medical Devices and Chemical Industries in the validation and regulatory fields.
Log on now to our website http://www.qrcgroup.com/ to learn more about our services and solutions!
Job Description
Validation Engineers to support the internal development and validation of a multi-dose preservative-free (MDPF) nozzle subsystem and any other miscellaneous project related deliverables as they arise.
Location: SouthEast, United States (Travel Required)
Scope Includes:
- Validation of new molding and assembly units
- Qualification of ISO7 clean rooms
- Integration of metrology instruments and handling systems
- Execution of IQ/OQ/PQ protocols, FAT/SAT, and traceability documentation
- Collaboration on a comprehensive Validation Master Plan
Location: SouthEast, United States (Travel Required)
Qualifications
- Bachelor’s in Engineering (Mechanical, Biomedical, Chemical, or Industrial)
- Location: SouthEast, United States (Travel Required)
Technical Skills
- IQ/OQ/PQ protocol development and execution
- FAT/SAT testing and documentation
- Validation Master Plan (VMP) creation
- MES/SCADA system qualification
- Injection molding and automated assembly validation
- Metrology equipment calibration and Gage R&R
- Traceability Matrix development
- Experience with KNEAT software (highly desirable)
Regulatory Knowledge
- FDA 21 CFR Part 820
- EU MDR 2017/745
- ISO 13485 & ISO 14971
- GMP compliance
Certifications
- ISO 13485 Quality Management
- ISO 14971 Risk Management
- GMP Training
- Six Sigma (Green or Black Belt)
Soft Skills
- Strong documentation and report writing
- Cross-functional collaboration
- Ability to train personnel
- Analytical thinking and problem-solving
Location: SouthEast, United States (Travel Required)
Additional Information
All your information will be kept confidential according to EEO guidelines.
Average salary estimate
If an employer mentions a salary or salary range on their job, we display it as an "Employer Estimate". If a job has no salary data, Rise displays an estimate if available.
Gain hands-on continuous improvement experience at Cornerstone Building Brands as a CI Intern supporting process improvement projects, documentation, training, and KPI tracking.
Lead the clinical QA strategy for ABA at Brellium, using clinical expertise and AI-driven insights to improve documentation, compliance, and operational quality across provider networks.
Experienced Medical Device ISO 13485 Lead Auditor needed to perform client-facing audits, mentor audit teams, and support audit practice development for a leading MedTech CRO.
EHS Intern at Clarios’ Toledo manufacturing plant to support hazard hunts, incident investigations, and lockout procedure development during Summer 2026.
A Clinical Quality Coordinator (RN) role at Emory Healthcare focused on data abstraction, regulatory reporting, and clinical performance improvement to advance patient safety and quality outcomes.
Solventum seeks a Quality Engineer in Irvine to support medical device quality systems, investigations, and product compliance initiatives.
Flock Safety is hiring a Device QA Engineer II to own manual testing and help build a scalable QA framework for Android-based safety devices and companion apps.
Lead Medical Laboratory Scientist at Dallas Regional Medical Center responsible for advanced testing oversight, quality control, and mentoring laboratory staff on the night shift.
Experienced EHS Engineer needed to lead regulatory compliance, audits, incident investigations and sustainability initiatives at a tier-one automotive manufacturing facility.
Experienced food safety leader needed to direct corporate food safety programs and regulatory compliance for a rapidly growing employee-owned supermarket chain headquartered in Boise.
AbbVie is hiring a Senior Scientist, Quality Control for an onsite, one-year contract to perform GMP analytical testing and support product/material release in Barceloneta, Puerto Rico.
Assurant is hiring an on-site NPI/Tool Validation Specialist in Irving, TX to lead product introductions and validate tools and integrations for high-volume consumer electronics manufacturing.
Benedictine seeks an Infection Preventionist (RN) to lead infection surveillance, prevention, and outbreak control at its St. Louis senior care community.
🔮
Hi, I'm Risa! Your AI Career Copilot
you, just ask me below!
