Quality Assurance Manager

Neurolief is a fast-growing medical device company developing and commercializing innovative

neuromodulation therapies. We are ISO 13485 certified and currently in an active scale-up phase. We are

seeking an experienced Quality Assurance Manager to join our team.

This is a hands-on leadership role in a highly regulated environment, responsible for building,

maintaining, and continuously improving the Quality Management System across development,

manufacturing, and global regulatory activities.

Key Responsibilities:

• Ensure Quality Compliance.
• Responsible for leading products quality and reliability process, systems, and culture to meet and exceed customer expectations and advance continuous improvement culture throughout the organization.
• Responsible for setting and achieving quality goals and metrics associated with Key Performance Indicators.
• Support of new product development programs.
• Supports global registration of products in the EU, US and Japan. Preparation and maintenance of Technical Files.
• Manage manufacturing quality assurance.
• Miantain the required processes to ensure that quality standards are implemented in accordance with corporate goals.
• Ensures the proper interface of the quality function to product development, manufacturing, engineering/maintenance, and other areas as required.
• Manages key processes such as CAPA, Customer Complaints, Training, Suppliers, MRB, Internal audits, Management Review etc.
• Manages internal audits in the company.

Requirements:

• Degree in engineering or other scientific discipline.
• At least 3 years experience of QA leadership in the Medical Device industry.
• Experienced with FDA Regulation, ISO 13845, ISO 14971, ISO 10993 and MDR.
• Fluent English.
• Experience with QA of medical products that integrates Hardware & Software.
• Experienced with Simploud, Dynamics and Arena - an advantage.