Job Description

• We are urgently hiring three Manufacturing Engineers with strong experience in medical device manufacturing and remediation.
• These roles will focus on remediation activities, process optimization, and ensuring compliance with regulatory standards.
• The ideal candidates will bring expertise in validation, CAPA, and risk management, while working cross-functionally to resolve compliance gaps and strengthen manufacturing operations.

• Remediation Initiatives.
• Lead remediation projects by identifying and addressing root causes of product or process deficiencies.
• Develop and implement Corrective and Preventive Actions (CAPAs) and remediation action plans.
• Conduct gap analyses of processes, documentation, and equipment to ensure compliance.
• Manufacturing Process Engineering.
• Design, implement, and optimize manufacturing processes to improve efficiency, quality, and compliance.
• Apply Design for Manufacturability (DFM) principles to reduce risks and streamline production.
• Troubleshoot and resolve production issues with robust, sustainable solutions.
• Quality & Validation.
• Support process and product validation activities, including IQ/OQ/PQ and test method validation.
• Perform and document risk assessments (FMEA, PFMEA).
• Ensure remediation actions are verified and documented in line with QMS and regulatory standards.

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