QMS Director

Vectorious has developed the world’s first in-heart microcomputer and is on a mission to transform heart failure treatment. As part of our first in-human clinical study, we have successfully implanted our sensory device in patients across Europe, while demonstrating a huge potential in helping millions of people living with heart failure to take control and manage their disease.

Now, we are looking for an QMS Director to join our QA department

Responsibilities

• Ensure that quality and regulatory related activities are implemented in accordance with the company’s quality manual
• Develop and Maintain the QMS procedures including procedures, templates and forms
• Ensure that quality system requirements and that processes needed for the quality management system are established, documented and effectively maintained in accordance with Vectorious’ policy & objectives
• Report on the performance and effectiveness of the quality management system to management with executive responsibility and as appropriate need for improvement
• As appropriate, provide quality and or regulatory training and ensure the promotion of awareness of applicable regulatory requirements and quality management system requirements throughout the organization
• Set quality requirements derived from company’s policy and quality objectives
• Handling external audits by notified body, auditing organizations and regulatory authorities
• Overview of supplier qualification, evaluation and control process
• Plan and manage implementation of internal quality audits and related findings
• Overview of training planning and effectiveness
• Manage, monitor and follow up required correction, corrective actions and preventive actions
• Analyze gathered data from production, customer support and R&D to determine whether objectives/requirements related to the product were met
• Preparing data required for management review input and summarize management review output
• Promote the awareness of regulatory and customer requirements throughout the organization
• Overview complaints handling process and as appropriate reporting to regulatory authorities
• Other duties as assigned

Qualifications

• At least 5 years of experience in QA/QMS management at Medical Device company
• Proven experience in establishment and / or management of quality systems in compliance with ISO 13485, preferably for a multi-disciplinary product
• Proven experience in leading CE / ISO 13485 / FDA-QSR audits
• Academic graduates in the field of Engineering or Life Sciences
• Fluent verbal and written English