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.Experience:4-6 YearsBachelor´s Degree:Industrial Engineering, Electronics Engineering, Biomedicine Engineering.Celestica is an equal opportunity employer. All qualified applicants will receive consideration for employment and will not be discriminated against on any protected status (including race, religion, national origin, gender, sexual orientation, age, marital status, veteran or disability status or other characteristics protected by law).At Celestica we are committed to fostering an inclusive, accessible environment, where all employees and customers feel valued, respected and supported. Special arrangements can be made for candidates who need it throughout the hiring process. Please indicate your needs and we will work with you to meet them.COMPANY OVERVIEW:Celestica (NYSE, TSX: CLS) enables the world's best brands. Through our recognized customer-centric approach, we partner with leading companies in Aerospace and Defense, Communications, Enterprise, HealthTech, Industrial, Capital Equipment and Energy to deliver solutions for their most complex challenges. As a leader in design, manufacturing, hardware platform and supply chain solutions, Celestica brings global expertise and insight at every stage of product development – from drawing board to full-scale production and after-market services for products from advanced medical devices, to highly engineered aviation systems, to next-generation hardware platform solutions for the Cloud. Headquartered in Toronto, with talented teams spanning 40+ locations in 13 countries across the Americas, Europe and Asia, we imagine, develop and deliver a better future with our customers.Celestica would like to thank all applicants, however, only qualified applicants will be contacted.Celestica does not accept unsolicited resumes from recruitment agencies or fee based recruitment services.#J-18808-Ljbffr
