Quality Assurance Engineer

Responsibilities

• The Quality Assurance Engineer is responsible for ensuring that all turnkey sanitary process systems comply with applicable regulatory, quality, and customer requirements.
• 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.
• Conduct root cause analysis and implement corrective and preventive measures (CAPA).
• Implement and maintain the Quality Management System.
• Organize company certifications, e.g., ISO 9001.
• Prepare annual management reviews for the Board of Management.

• Bachelor’s degree in engineering (Mechanical, Chemical or related field) or equivalent experience.
• International Welding Engineer (preferred).
• 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 Whys, 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).

Demonstrates expertise in Quality Assurance and Quality Control within sanitary process systems, ensuring compliance with regulatory standards and customer requirements. Proficient in conducting inspections, managing non‑conformities, and implementing corrective actions while maintaining a robust Quality Management System.