Quality Assurance Engineer

Krones Process Group North America LLC•Franklin, WI

7h•$70,000 - $120,000•Hybrid

About The Position

The Quality Assurance Engineer is responsible for ensuring that all turnkey sanitary process systems—design, fabrication, installation, and commissioning—comply with applicable regulatory, quality, and customer requirements. This role supports an entire project lifecycle, ensuring hygienic design standards, documentation integrity, and validation readiness for industries requiring strict sanitary and regulatory compliance.

Requirements

Bachelor’s degree in engineering: (Mechanical, Chemical or related field) or equivalent experience
3 – 8 + years of QA / QC experience in sanitary and hygienic process systems (tubing and piping)
Experience in the pharmaceutical, biotech, or food processing industry
Hands-on experience with hygienic piping systems, skid fabrication, or process equipment
Comprehensive knowledge of hygienic design principles and stainless-steel fabrication (304/316L)
Comprehensive knowledge of manual TIG welding and TIG orbital welding and inspection method
Standard knowledge of P&IDs and isometric drawings and 3D models
Standard knowledge of QA documentation and Qualification and Validation (DQ/OQ/IQ)
basic knowledge of root cause analysis (e.g. 5?, Fishbone)
basic knowledge of quality management KPIs and statistical process control
Strong attention to detail and documentation accuracy
Excellent communication and cross-functional collaboration
Problem-solving mindset with a proactive approach
Ability to manage multiple projects and priorities

Nice To Haves

International Welding Engineer (preferred)
ASQ Certified Quality Engineer (CQE) or CQA
Certified Welding Inspector (CWI)
ASME BPE familiarity or training
Six Sigma (Green Belt or higher)

Responsibilities

Prepare inspection test plans (ITPs) and corresponding documents (e.g. test reports)
Ensure compliance with customers’ standards and regulatory requirements
Prepare company standards and technical specifications
Conduct acceptance tests internally and qualifications and validations externally with customer
Perform Welding Supervision and support Site Management
Supplier management support and monitoring fabrication quality
Identify, monitor, document and handle non-conformities
Conducting root cause analysis and implementing corrective and preventive measures (CAPA)
Practice and drive the management system for continuous improvement (PDCA or KAIZEN)
Conduct Design Acceptance Test (DAT) internally with process engineering and 3D design
Coordinate Design Qualification (DQ) with customer
Compile and review turnover packages and maintain finalized and audit-ready documentation
Perform quality assurance and audit subcontractors (on-site) and fabricators (pre-fabrication)
Conduct factory acceptance tests (FAT) at fabricators’ facilities (e.g. tanks or skids)
Conduct site acceptance tests (SAT) of installed or assembled plants or machines
Monitor and check welders site test before welding on site
Monitor on-site welding quality
Conduct borescope inspection
Review and check suppliers’ technical documentation
Implement and maintain the Quality Management System
Organize company certifications, e.g. ISO 9001
Coordinate and support internal audits external audits with CBs or NRTL and AHJ
Project management support and project coordination support
Preparing annual Management Reviews for the Board of Management