Quality Assurance Engineer

Jobtailor; Franklin (WI); On-site; USD 85,000 - 115,000; Full time

Job summary

Jobtailor is seeking a Quality Assurance Engineer to ensure that turnkey sanitary process systems meet regulatory, quality, and customer requirements. You will prepare ITPs, test reports, and oversee QA documentation and CAPA activities.

The role covers internal acceptance tests, external qualifications with customers, welding supervision, supplier quality monitoring, and maintaining ISO 9001 and the Quality Management System across projects in the pharmaceutical, biotech, or food processing

Qualifications

• Bachelor’s degree required in engineering or equivalent experience.
• International Welding Engineer certification 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 CQE or CQA; ASME BPE familiarity or training.
• Six Sigma (Green Belt or higher).

Responsibilities

• The QA Engineer ensures turnkey sanitary process systems comply with 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 CAPA.
• Implement and maintain the Quality Management System.
• Organize company certifications, e.g., ISO 9001.
• Prepare annual management reviews for the Board of Management.

Skills

Quality Assurance

Quality Control

Root cause analysis

Statistical process control

Six Sigma

Education

Bachelor’s degree in engineering

Tools

TIG welding

TIG orbital welding

3D models

QA documentation systems

Job description

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.

Requirements

• 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).

Core Competencies

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.