Job Purpose or Job SummaryThe 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.
Essential Duties and ResponsibilitiesQuality Assurance and Product Quality
- 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
Handling non-conformities
- 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)
Qualification and Validation Support
- 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
Supplier Management Support and Fabrication Quality
- 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
Quality Management
- 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
Required qualificationsEducation
- Bachelor's degree in engineering: (Mechanical, Chemical or related field) or equivalent experience
- International Welding Engineer (preferred)
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
Technical Skills
- 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 and
- 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
Additional Certifications (preferred)
- ASQ Certified Quality Engineer (CQE) or CQA
- Certified Welding Inspector (CWI)
- ASME BPE familiarity or training
- Six Sigma (Green Belt or higher)
Soft Skills
- 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
Physical / Working Demands- The work environment is a professional office environment where a conservative business dress code is in effect. The noise level in the work environment is usually moderate.
- visits to manufacturing shops, supplier facilities, and project installation sites active as needed.
- While performing the duties of this job, the employee is regularly required to sit, use hands to type, handle, or feel; and talk or hear.
- Specific vision required by this job includes close vision, distance vision, and the ability to adjust focus.
- Equipment used includes a computer, calculator, and measuring devices.
- Ability to understand both spoken and written directions and good vision required.
- Personal protective equipment required includes protective-toed safety shoes, safety glasses with side shields and hard hat (when on an active job site).
- All employees are required to maintain a safe working environment and comply with all safety and environmental policies/procedures. Each employee is to place environmental health and safety requirements as the priority in the performance of their work duties. Employees are responsible for notifying their immediate supervisor of a violation or deficiency in working conditions and recommending corrective measures, if possible. The employee's immediate supervisor must also be notified of every injury, or near miss.
- Travel will be required (10-25%)
* The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.
