Validated knowledge of iso 13485 and fda regulations
Experience with capa, complaints, and risk management
Baxter Healthcare is seeking a Senior Quality Systems Engineer for their Cartago, Costa Rica location, focused on ensuring compliance with regulatory standards and driving quality system efficiency. The ideal candidate should possess a minimum of four years' experience in quality systems and regulatory compliance within the healthcare device sector
Job Summary
This role combines responsibilities in CAPA, Complaints, Risk, Internal Audit, and Regulatory Affairs to ensure conformity with regulatory mandates.
The successful candidate will own the Complaints, CAPA, Risk Management, and Hold systems while driving the efficiency of quality systems at the Baxter Cartago plant.
Baxter is united by a mission to save and sustain lives, fostering a culture of courage, trust, and collaboration where every individual is empowered to make a meaningful impact.
Matching Summary
Match Score: 85
Baxter Healthcare is seeking a Senior Quality Systems Engineer for their Cartago, Costa Rica location, focused on ensuring compliance with regulatory standards and driving quality system efficiency. The ideal candidate should possess a minimum of four years' experience in quality systems and regulatory compliance within the healthcare device sector.
Skills & Requirements
Must-have
4+ years manufacturing quality systems experience
Validated knowledge of ISO 13485 and FDA regulations
Experience with CAPA, Complaints, and Risk Management
Internal Auditor certification and auditing system experience
Knowledge of Sterility Assurance processes
Nice-to-have
Strong communication skills for cross-functional collaboration
Experience with MDSAP and CMMI frameworks
Proven ability to lead root cause analysis initiatives
Commitment to a culture of courage and trust
Key Requirements
Minimum 4 years experience in healthcare device manufacturing