Senior Quality Engineer- Design Quality – Lifecycle Management
Core
Ensure medical device products are properly transferred from development to manufacturing and maintained on market while assuring compliance to local, divisional, and corporate policies and external agency regulations worldwide.
Role type
Senior Quality Engineer (Design Quality – Lifecycle Management)
Builds
Medical devices and combination products (infusion pumps, tubing, syringes, autoinjectors, eyecare products, aesthetic devices)
Domain
Medical Devices / Regulatory Compliance / Quality Systems
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Design control, Risk management, Change management, Supplier management, Regulatory submission documentation, Equipment qualification (IQ/OQ/PQ), Process validation, CAPA investigation, Audit support, Global regulations knowledge
Preferred skills
Cross-functional leadership, Continuous improvement, Policy/procedure writing, Impact assessment
Technologies
Quality System tools, DHF documentation systems, Regulatory submission platforms
Responsibilities
Perform QA activities for design transfer and change management; Maintain DHF documentation; Partner with operations to ensure design control and risk management requirements are met; Support creation of regulatory submission documentation; Serve as primary quality lead for design transfer activities; Support equipment qualifications and process validations; Manage on-market design changes and execute action plans; Identify gaps in Design History File and Risk Management; Lead or participate in investigations and review boards for CAPAs; Conduct departmental Change Control activities; Support interactions with regulatory authorities; Write and revise procedures and forms
Seniority
Senior, hands-on IC
