Job Overview

The Quality Manager has the overall responsibility of developing and maintaining Disior Quality Management System. This role will lead the Disior Quality Management System processes based on the ISO 13485 standard and participate in all phases of the medical software development lifecycle based on IEC 62304 and ISO 14971 standards. The successful candidate will be responsible for ensuring the quality and compliance of Disior medical image analytics software in the European and USA markets, with an aim for global market expansion.

Essential Responsibilities and Duties

• Develop and maintain the Disior Quality Management System

  • Own the monitoring and reporting activities around the Disior key processes.

  • Monitor and report on Disior's key processes and facilitate management reviews and QMS process risk assessments.

  • Perform internal audits and participate to external audits.

  • Screen external sources for changes in regulations and standard compliance, including product post-market surveillance.

  • Based on the performance metrics, business needs and changes in the requirements, lead updates to the QMS and processes as a continuous improvement.

  • Participate in integration activities of Disior QMS to our parent company Paragon 28.

• Working as a part of the design team and in close collaboration with the customer-facing teams:

  • Facilitate operating mechanisms to ensure compliance with standard and regulatory requirements of the design.

  • Coach team members to operate according to the quality management system processes

  • Participate in the regulatory submissions of our medical software products.

• Develop the Quality culture by driving compliance activities around our medical software family.

  
  

Qualifications

• Master's or Bachelor's degree in a technical/scientific/medical discipline or experience in medical technology

  • Experience with software development and quality management would be advantageous.

• Minimum 5 years professional work experience.

• Familiarity with quality and product development standards, mainly ISO 13485, IEC 62304, and ISO 14971. Prior knowledge regarding software quality assurance and cybersecurity is beneficial.

• A data-driven mindset. You see value in the information built from the data analytics and want to strategically improve our quality operations as the business is growing.

• You are a self-starter, passionate about the impact doctors have on patient lives and the healthcare industry in general.

• Fluent verbal, written and presentation skills in English. Other languages a plus but not necessary.

• Proficiency with the Office tools, such as Microsoft Word, Excel, PowerPoint, Outlook

Work Environment

This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones and copy machines.

Physical Demands

The work is typically performed in a normal office environment without specific physical demands.

While performing the duties of this job, the employee is regularly required to communicate with individuals internal and external to the organization.

Position Type/Expected Hours of Work

The location of this position is in Helsinki, Finland. This is a full-time position with typical business hours and is eligible for a hybrid schedule of work from home/office.

Travel

0% - 10% of overnight international travel required or may be required.