About us :

Natec Medical is a global leader specializing in the design and production of endovascular devices.

With nearly three decades of industry-leading manufacturing experience, we operate as a world-class CDMO (Contract Development and Manufacturing Organization). This means global healthcare brands trust us as an all-in-one partner to handle the entire journey of a medical device under one roof: from the initial design and prototyping, through to rigorous safety testing, cleanroom manufacturing, and final sterilization.

To support our growing capabilities, we recently relocated our operations to the state-of-the-art AVA Technopark in Mauritius- the region’s premier technological park dedicated entirely to medical devices technology. From this modern infrastructure, we combine decades of engineering discipline with advanced precision to build products that save patient lives around the world

About the Role

The Quality Engineer ensures quality assurance oversight across the entire product lifecycle, beginning with Design & Development activities, followed by supplier qualification and control, manufacturing oversight, and post-market surveillance including customer complaints. The role ensures that products comply with Natec’s specifications, the Device Master Record (DMR), and applicable regulatory requirements (ISO 13485, 21 CFR 820). Through structured risk management, investigation of nonconformities, supplier control, process validation support, and effective CAPA and Change Control implementation, the Quality Engineer strengthens product robustness, regulatory compliance, and customer satisfaction across all stages of the lifecycle

Main Accountabilities

Quality Assurance

• Ensure that purchased components meet specifications and quality standards.
• Investigate and manage nonconforming components received from suppliers.
• Qualify new suppliers and establish quality agreements.
• Ensure that manufactured products conform to Natec’s specifications and the DMR (Device Master Record).
• Investigate and manage nonconforming products and deviations from the DMR.
• Support product and process changes in accordance with Change Control procedures, including changes to purchased components, and coordinate with Regulatory Affairs when required.
• Review and approve updates to the DMR (e.g., work instructions).
• Conduct regular factory walkthroughs on the shop floor to assess compliance with DMR and Good Manufacturing Practices (GMP).
• Investigate and manage customer complaints.
• Inspect products returned from the field.
• Liaise with the Training Team to provide market feedback to production operators.
• Assist Regulatory Affairs in notifying competent authorities of serious adverse events.
• Ensure that design and development activities comply with applicable regulations, standards, and Natec’s Quality Management System.
• Review deliverables from projects and the Design History File (DHF).
• Ensure that design inputs and outputs, as well as verification and validation activities (V&V), are complete, relevant, and traceable.
• Participate in internal audits, as well as audits conducted by Notified Bodies and Competent Authorities.
• Support the investigation and implementation of CAPA (Corrective and Preventive Actions), including Supplier Corrective Action Requests (SCAR), for both internal issues, supplier-related nonconformities, and customer complaints.

Quality Management System

• Actively contribute to the implementation, maintenance, and continuous improvement of the Quality Management System in accordance with ISO 13485 requirements, ensuring effective application within their area of responsibility.

Compliance

• As an ambassador of compliance within the organization, the Quality Engineer promotes a culture of quality by encouraging adherence to established rules and standards. They are also responsible for defining and maintaining the procedures necessary to ensure the compliance of the Quality Management System with applicable regulations and standards.

Qualifications & Experience

• A degree in engineering, pharmacy, or a Master’s degree in a relevant scientific discipline such as materials science, microbiology, or mechanical engineering is required.
• 2-3 years of experience in Quality, R&D, or Production within a highly regulated industry.

Skills & Attributes

• Solid understanding of quality standards and regulations (particularly ISO 13485 and 21 CFR Part 820).
• Familiarity with risk management principles in accordance with ISO 14971.
• Good command of special process validation principles (e.g. sterilization, packaging, bonding or coating).
• Proficiency in statistical techniques and use of tools such as Minitab or equivalent.
• Ability to plan, conduct, and follow up on audits (internal and supplier audits).
• Fluent in English (both written and spoken).
• Strong structured problem-solving abilities.

How to Apply

Interested employees are encouraged to submit their applications by 25/10/2026

Please include:

• An updated resume & motivation letter

Submit your application by e-mail to Dominique Aza: daza@natec-medical.com with subject ‘Quality Engineer’ as e-mail subject..