Sr. Quality Applications Specialist
On-siteVillalba, Lazio, Italy
Job Summary
Conduct compliant validation processes for quality information technology systems, including formal documentation, system administration, and configuration. Coordinate activities with clients, programmers, and operating personnel while identifying requirements for compliant computerized operations. Lead FCA and CAPA processes, perform process failure mode analysis, and support product transfer activities for sterilization machines. Report validation status to fulfill regulatory requirements and keep abreast of changing federal and international regulations. Manage multiple priorities with strong project management skills to implement effective corrective actions.
Required Qualifications
- Bachelor's Degree in Engineering or Science
- eight (8) years of exposure within the Medical Devices Industry
- strong background in field corrective actions, CAPA, or product quality management
- Bilingual: Spanish and English
- Excellent teamwork skills
- Experience in equipment IQ, OQ, and PQ and/or process validation
- Process Validation Lifecycle
- Preferred experience in DOE
- Computer and software validation
- SOP Development
- Change control of Medical Devices
- Experience with process failure mode analysis and first-time quality
- Solid understanding of FDA regulations (21 CFR Part 820), ISO 13485, EU MDR, and other relevant medical device regulations
- Proven experience leading FCA and CAPA processes, ideally within a medical device or regulated industry
- Strong project management skills, with the ability to manage multiple priorities and deadlines
- Excellent problem-solving and analytical skills, with the ability to identify root causes and implement effective corrective actions
- Outstanding communication and interpersonal skills, capable of effectively working with cross-functional teams and external stakeholders
- Proficiency in quality management systems
- Strong technical writing capability
- Shift: 1st, and according to business needs
Desired Qualifications
- Preferred experience in DOE
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