Quality Management System Manager

at  Injurymap

Company Overview:
Injurymap is a Danish health tech company with high growth ambitions. Our mission is to disrupt the market for pain and injury treatment to improve patient outcomes and efficiency across the entire value chain. Today, we sell digital, virtual, and physical treatment via health insurer partners.
We are at the forefront of digital physiotherapy, committed to redefining the landscape of injury recovery through advanced technological solutions. Currently, we are a small and passionate team consisting of programmers, business developers, and physiotherapists, in total approx. 20 people.
Job Summary:
We are looking for a highly motivated Quality Management System (QMS) Manager to spearhead our quality assurance initiatives. The QMS Manager will play a crucial role in developing, implementing, and enhancing our Quality Management System to ensure full compliance with the Medical Device Regulation (MDR) and other applicable standards. This position is critical in maintaining our reputation for high-quality digital health services and solutions.

Key Responsibilities:

• Lead the development, implementation, and maintenance of a comprehensive Quality Management System (QMS) in alignment with the EU Medical Device Regulation (MDR) and ISO 13485 standards.
• Prepare and guide the company through external quality audits and inspections, focusing on compliance with MDR requirements.
• Collaborate with various teams to integrate quality management principles across the product development lifecycle, ensuring that all products meet the highest regulatory and quality standards.
• Manage QMS documentation, ensuring accuracy, completeness, and compliance with MDR and other relevant standards.
• Conduct internal audits to identify improvement opportunities within the QMS and oversee corrective and preventive action (CAPA) initiatives.
• Provide ongoing training and support to team members on MDR compliance, quality management practices, and changes in regulatory landscapes.
• Stay informed of regulatory updates and trends in the digital health industry, especially related to MDR, to ensure Injurymap’s practices are current and compliant.
• Ensure that quality assurance and regulatory compliance are seamlessly integrated into product design and delivery, working closely with product development and clinical teams.

Qualifications:

• Bachelor’s or Master’s degree in Quality Management, Biomedical Engineering, or a related field.
• At least 5 years of experience in quality management systems, specifically within the healthcare, medical device, or digital health sectors, with a focus on MDR compliance.
• Comprehensive understanding of the EU Medical Device Regulation (MDR), ISO 13485, and risk management processes.
• Demonstrated success in managing QMS and conducting external audits under MDR regulations.
• Excellent leadership, analytical, and project management skills, with the ability to foster a culture of quality across departments.
• Strong communication skills, adept at explaining complex regulatory requirements in clear terms.
• Detail-oriented with a commitment to precision and the ability to juggle multiple priorities in a dynamic environment.

What We Offer:

• A role at the forefront of digital health innovation with the potential to positively impact patient outcomes globally.
• A collaborative, supportive work environment that values innovation and quality.
• Competitive salary, and opportunities for professional growth.

Injurymap
Kööpenhamina
Kokopäiväinen
Julkaistu 18.03.202

• Lead the development, implementation, and maintenance of a comprehensive Quality Management System (QMS) in alignment with the EU Medical Device Regulation (MDR) and ISO 13485 standards.
• Prepare and guide the company through external quality audits and inspections, focusing on compliance with MDR requirements.
• Collaborate with various teams to integrate quality management principles across the product development lifecycle, ensuring that all products meet the highest regulatory and quality standards.
• Manage QMS documentation, ensuring accuracy, completeness, and compliance with MDR and other relevant standards.
• Conduct internal audits to identify improvement opportunities within the QMS and oversee corrective and preventive action (CAPA) initiatives.
• Provide ongoing training and support to team members on MDR compliance, quality management practices, and changes in regulatory landscapes.
• Stay informed of regulatory updates and trends in the digital health industry, especially related to MDR, to ensure Injurymap’s practices are current and compliant.
• Ensure that quality assurance and regulatory compliance are seamlessly integrated into product design and delivery, working closely with product development and clinical teams