.Press Tab to Move to Skip to Content LinkSelect how often (in days) to receive an alert:07 - Analyst, Operations Quality General Overview Summary Description Company: Celestica Valencia S.A.Celestica is a Canadian company, world leader in the electronic manufacturing sector. The plant in Valencia focuses its activities in the Aerospace, Industrial and Healthcare areas, producing and assembling high complexity products.The main differentiator in Valencia facilities are its design capabilities and the various engineering services that it can provide to its customers, creating a differential value beyond the regular electronic manufacturing services.Area/Department: Healthcare Quality departmentThe Healthcare Quality department in Celestica Valencia is specialized in the assurance of the quality for current and new medical devices.Customers go from worldwide multinationals to startups with innovative ideas.The healthcare quality team is a young team in development with plenty of opportunities to grow.Name of the position:Customer Engineer HT - Complaint handling.Description:Customer Engineer will manage the interactions with customers and petitions of technical issues related to the product as well as define controls to assure the quality of the device.The role will engage with quality matters and will require the understanding of medical devices regulation (ISO13485 and FDA). Quality related activities mainly consist in: preparation of product quality plans, conduct and coordinate complaint investigation, CAPA coordination and execution, as well as change control management.For Complaint Handling:Monitoring and Analysis: monitor product performance in the field after commercialization. This involves analyzing and evaluating risks in the clinical setting.Risk Estimation: Risk estimation is crucial, and a cross-functional team of engineering and clinical experts estimates severity and occurrences.Feedback Loop: Establishing a robust feedback loop from post-market surveillance to risk management. This loop informs decisions about risk controls and future designs based on actual market performance.Regulatory Requirements: FDA's 21 CFR 820 Subpart M addresses complaint files, while 21 CFR 803 covers Medical Device Reporting. Future EU-MDR handling and reportingRisk Control Decisions: Risk management informs decisions about risk controls and future device designs. By monitoring complaints and assessing risk, you can identify unforeseeable hazards and ensure risks remain within acceptable levels.Knowledge/Skills/Competencies:- Fluent in English, spoken & written.- Knowledge of mechanical, electrical, electromechanical or bioengineering-biomedicine systems and principals of operations.- Knowledge of quality standards and problem solvent competency.- Knowledge of personal computers and Windows applications- Ability to effectively communicate with a variety of internal and external customers
