Philips Technical Services Manager 

Costa Rica 

765861726

Technical Services Manager

Role Overview

Manages, Sterilization, Microbiology and Calibrations. Work primarily with IGT Devices products and processes that require sterilization and/or environmental controls used in the development or manufacture of Intravascular Ultrasound and Functional Measurement medical devices.

Responsibilities

• To formulate and implement the Business’ long-range quality, regulatory and compliance policy
• Create Q&R awareness level as determined within the organization.
• Enforces (a simplified) quality systems and harmonizes them across the Business sites and Sector; establish an effective Management Review process, including routine reporting.
• Introduce and implement the quality processes and tools required to ensure product quality and customer satisfaction.
• Manages compliance to FDA regulations and other Regulatory Agencies as required, guidelines and policies to all products and operations are consistent with those regulations.
• Manages the review and approval of finished products manufactured for and by the company in accordance with their approved specifications. Includes Complaint handling
• Manages all inspections and questions relating to the operation of the manufacturing sites in coordination with all other applicable company groups.

Requirements

• Bachelor degree in Microbiology, Engineering, Biotechnology Engineer, Chemical Engineer, or a combination of equivalent job experience in related field.
• 5 years of experience in the field.
• Advance-intermediate English knowledge written and spoken.
• Office knowledge (Visio, word, excel, PowerPoint).
• Statistical and Quality Tools knowledge.
• Problem Solving skills.
• Validation Knowledge
• Minitab Knowledge
• AAMI Sterilization Workshop
• AAMI Industrial Sterilization
• Administrative Shift

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