Quality Management Expert
On-siteDonji Stupnik, Zagreb County, Croatia
Job Summary
Lead high-risk supplier audits, internal system audits, and investigations into non-conformities while acting as the primary reviewer for R&D Validation & Verification plans. Conduct Root Cause Analysis using advanced tools like Fault Tree Analysis and 8D for critical issues, manage recertification cycles for ISO and ASME standards, and oversee the execution of the "Graded Approach" to quality. Develop Quality Assurance Plans for major international nuclear projects, approve special process validations, and verify the effectiveness of Corrective and Preventive Actions. This role supports the transition to new standards such as ISO 19443 and mentors Specialists and Associates within the Quality Management Department at INETEC.
Required Qualifications
- Minimum Bachelor's degree in a technical field
- A minimum of 7 years of relevant professional experience
- at least one year in QA/QC within the nuclear sector
- Advanced knowledge of mapping, analysis and optimization of complex cross functional processes (R&D to Production)
- Understanding of fundamental quality concepts (PDCA cycle)
- Ability to generate detailed Non-Conformity Reports (NCR) and Corrective Action Plan (CAP) effectiveness analyses
- Application of process monitoring techniques
- Advanced knowledge of internal audit and supplier audit methodologies
- Knowledge of independently conducting internal audits and supplier audits
- Creation of deep dive technical reports for regulatory bodies and customers
- Advanced knowledge of accurate data entry requirements in QMS software
- Basic understanding of data integrity principles
- Advanced knowledge of Document Management System (DMS) architecture and workflow automation
- Experience with ERP systems for quality-gate configuration and goods release processes
- Advanced use of MS Word and Excel for quality data analysis
- Proactive and solutions-oriented approach, resolving challenges effectively, and building a cooperative and trust-based work environment
- Advanced proficiency in spoken and written English
- Possession of a Certified Lead Auditor qualification (ISO 9001)
- Advanced knowledge of ASME NQA 1 Lead Auditor requirements
- Advanced knowledge on ASME BPVC Section III/V/XI, with the ability to interpret 'grey areas' in regulations and defend positions during external audits
- Knowledge of ISO 19443 (nuclear energy – nuclear supply chain quality management)
- Experience with ASME NQA-1 requirements for design control and document control
- Understanding of GDPR and information security principles (ISO 27001) in the context of QA
- Ability to interpret complex NDT validation data and correlate it with quality objectives
Desired Qualifications
- Experience with NDT equipment manufacturers or in-service inspection providers
- ISO 14001 and 45001 Lead Auditor qualifications
- Knowledge of ISO/IEC 17025 requirements for calibration and testing laboratories
- Advanced knowledge of Lean Six Sigma methodologies for reducing waste and variability in nuclear manufacturing
- Ability to map business processes and identify bottlenecks
- Ability to follow process maps and Standard Operating Procedures (SOPs) strictly
- Advanced knowledge of statistical process control (SPC) analysis
- NDT experience and certification (VT, PT, ET, UT preferred)
- Knowledge of automated testing equipment software
- Advanced use of statistical analysis tools
- Possession of a Certified Lead Auditor qualification (ISO 14001, 45001)
- Possession of a Certified Quality Engineer (CQE) certification or equivalent experience
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.