JT678 - QUALITY APPLICATIONS SPECIALISTS
On-siteVillalba, Lazio, Italy
Job Summary
Conduct a compliant validation process for quality information technology systems, including formal documentation and standard operating procedures under federal regulations. Coordinate activities with clients, programmers, developers, and operating personnel domestically and globally. Identify requirements for compliant computerized operations and suggest methods for implementing procedures to assure regulatory compliance. Report on validation activity status to fulfill regulatory requirements and keep abreast of changing federal and international audit policies. Work in the 1st shift at Quality Consulting Group, a leader in pharmaceutical and medical device industries.
Required Qualifications
- Bachelor's degree in Engineer or Science
- 10+ years of experience in the medical device industry
- Strong background in field corrective actions, CAPA, or product quality management
- 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
- Outstanding communication and interpersonal skills
- Capable of effectively working with cross-functional teams and external stakeholders
- Proficiency in Microsoft Office Suite
- Quality management systems (QMS)
- Strong technical writing capability
- Experience in equipment IQ
- Experience in OQ (Operational Qualification) and PQ (Performance Qualification)
- Process Validation Lifecycle (from process characterization, operational qualification to performance qualification)
- Computer and software validation CSV
- SOP Development
- Change control of Medical Devices
- 1st shift
Desired Qualifications
- Preferred experience in DOE (with minitab)
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