What we are looking for ?

As part of our latest innovative IoT Healthcare product Orizon, we are looking for a Quality Management System Manager, a motivated colleague with CSV and QMS experience to join our team responsible for the development of Software as a medical (and non-medical) device.
You will be responsible for introducing and maintaining a Quality Management System dedicated to marketed digital applications (Software as a Medical Devices) in a Life Cycle Management environment.
You will collaborate with both Group Quality, Digital Factory but also with all other stakeholders: regulatory experts, department heads of the different departments (sales, purchase, legal, supply chain), stakeholders on plant level, external stakeholders (consultancy, notified body, authorities…).

What is the scope ?

• Introduce and maintain Quality Management System processes within Digital Factory, especially on Orizon product
• Ensure that all different stakeholders within Digital Factory are informed of regulatory requirements related to the Quality Management System

What are my main responsibilities ?

• Introduce and maintain QMS processes and documentation maintenance in compliance with ISO 13485, ISO 27001, ISO 62304, IEC 82304, IEC 62366, ISO 14971, 21CFR 820, REGULATION (EU) 2017/745 and other relevant standards and regulations relevant for medical device manufacturers.
• Document control coordination and administration.
• Coordinating site-related Change Controls for processes and products
• Control and maintenance of Technical Documentation of medical device software products
• Supplier Quality Control regarding outsourced services and products
• Assisting in software validation, usability, and risk management activities
• Assisting is quality issues investigation, initiating and follow-up of CAPA, NCR
• Assisting in post-market surveillance actions
• Active participation into selection and training process
• Support Regulatory Affairs in product registrations for software as medical device
• Participate in global QA/RA projects
• Participating in Internal and External audits, support of local process owners during preparation to the audits and the audits follow-up
• Perform other related duties as assigned

What are the challenges ?

• Situations I encounter require constant adaptation or development of new solutions through analytical, interpretative, evaluative, creative and innovative thinking
• To find the solution I need to think within broadly defined policies and objectives

Educational requirement:

• Master degree (university or equal through experience) in engineering / science:
• Knowledge of Regulatory requirements as REGULATION (EU) 2017/745 and 21CFR820
• Knowledge of Management System Standards such as: ISO13485, ISO62304, ISO14971, etc.
• Knowledge of ICH-GCP guidelines and/or ISO 14155:2020 is an asset
• Fluent in English, any other language is considered as an asset

Experience:

• At least 5 years of Quality Management Systems relevant experience
• Experience with Jira and Confluence is a nice to have

Competencies:

• Analytical skills and communication skills
• Communication skills towards different teams in the organization
• Leadership skills to be able to push projects forward and take full accountability
• Project management in cross functional teams
• Proactively reduce hurdles
• Be able to create business partners within the organization
• Be able to prioritize

• First interview of 30 minutes via confcall to get to know each other
• Interview with the Orizon Product owner
• Interview with Quality Assurance Senior Manager South West Region Europe
& with the Head of Digital Factory