Validation Engineer

The Engineer generates manufacturing documentation, processing changes, supporting the Operation & Engineering staffs.

Engineer

Natec Medical

Based for 20+ years in Mauritius, Natec Medical Ltd is an integrated design, development and manufacturing company specializing in percutaneous interventional medical devices for the global market. We design and manufacture angioplasty balloon catheters for interventional cardiology, radiology, gastroenterology and urology.

Fully committed to setting the highest standards, we adapt to change with speed and determination.

Role

The Engineer generates manufacturing documentation, processing changes, supporting the Operation & Engineering staffs. The Engineer work with other functional groups, such as Document control, Quality, Regulatory Affairs, Research & Development, supporting new product development.

Ensures required documentation for new materials is in place for initial builds and testing using the DCF process. Works on complex mechanical problems where analyzing situations or data requires an in-depth evaluation. Exercise judgment within defined practices and policies in selection methods, techniques, and evaluation criteria for obtaining results. Determines methods, processes and procedures on new assignments and may provide guidance to others.

As Engineer, your main responsibilities are as follows:

-          Run process qualifications including Instillation Qualification, Operational Qualification and Performance / IQ OQ PQ

-          Develop, design and execute validation protocols

-          Review and approve design change control, validation protocols and reports

-          Coordinate and act as subject matter expert for Natec MVP, schedule, execution of schedule, validation policy and practice

-          Write, review and approve validation change controls and validation protocols IQ OQ PQ PV standard operating procedures, CAPAs reports

-          Perform training to procedural and quality system changes

-          Facilitate Risk Management process in compliance to appropriate external standards and corporate policies

-          Drive Quality Engineering activities designed to improve customer satisfaction and achievement of company quality objectives

-          Has advanced knowledge in the areas of Validation, Design Controls, Risk Management and Statistical Techniques

-          Responsible for ensuring compliance with all company regulations, policies and procedures

Education / Experience Requirements

• Minimum Bachelor Degree in Manufacturing / Mechanical engineering 
• 3 - 5 years work experience exposure in process and/or manufacturing environment

Skills & Qualifications

• Ability to perform root cause analysis for production issues
• Attention to details
• Able to conduct and interpret statistics
• Good knowledge in Microsoft Office
• Minitab will be an advantage
• Ability to work in team
• Good communication skills in both English & French, both written and verbal

Benefits:

-          Training plans

-          Medical Insurance

-          Transport or Fuel allowance

We invite you to join us and reach the opportunity to work in a company with a friendly work environment and the possibility to learn and grow in competences.

‘Our Mission is to save lives everyday for all’.

We thank you for your interest in our Company!