Quality Assurance Manager

Quality Assurance Manager
Viseu
Viseu, Viseu District, Portugal

Company Overview

Founded to transform lives through technology, Beats Medical is a world leader in the delivery of digital therapeutics and assessments for neurological conditions. We turn your smartphone into a medical device and provide daily assessments and therapies in the home. Our core values are that of empathy, integrity, sense of urgency to create change and empower our users to take control of their conditions. We want to greater understand CNS and Rare disease to help inform how they are managed and treated now and into the future.

This is a chance to join a growing international tech company dedicated to transforming lives and healthcare through technology. In this role you will work within a highly engaged development team based in Dublin and Lisbon comprising of a team of commercial, developers and designers with embedded product and quality assurance functions.

What are we looking for?

We are looking for a Quality Assurance Manager that empowers our product team to deliver high quality software as a medical device that our customers love. A team member who is organised with strong documentation skills and who willing to be a voice for patient safety and product excellence. Our product team is composed of a mobile developers, backend developers and design team who work alongside clinicians, researchers and the commercial team all driven to deliver the best outcomes for our customers.

Your Profile:

• B. S. or M. S. degree in Healthcare Science, Engineering, Computer Science
• 5+ years of Quality Assurance and Project management experience with a quantifiable record of achievement with an ability to analyze and challenge data, identify and address gaps, and generate technical reports
• Solid understanding of the SDLC (software development life cycle) phases Successful record of implementing and maintaining a QMS
• Experience with ISO9001, ISO 13485, and risk management and regulatory procedures pertaining to quality assurance
• Persistence to ensure that all operations are meeting security and quality standards
• Comfortable working with a remote and distributed team
• Demonstrated project and team leadership skills with the ability to track and report progress against established milestones, metrics and deliverables
• Ability to work independently in a dynamic, growing entrepreneurial environment Fluent in written and spoken English
• Strong interpersonal skills, with the ability to communicate with people working in all departments including pharma clients and regulatory authorities
• Excellent oral, written and presentation communication skills
• Impeccable organisational skills

Role

• Managing and maintaining an established Quality Management System
• Management of the software development lifecycle works closely with design, product, clinical and data teams to map out projects for success
• Ensuring all QMS documents are updated and followed for each phase of development
• Documenting, implementing and
  - ordination of development activities to include: requirements, process development, procedures, risk management planning and specifications
• Application testing and reporting to ensure product quality requirements are met
• Develop and update documentation relating to equipment or processes to develop the device in a controlled manner in line with regulatory standards
• Ensure product meets clients specifications within defined deadlines and quality standards
• Adhere to best practices based on our established Quality Systems requirements for medical devices and security
• Support
  - related activities for medical device development, ensuring controls are implemented, maintained and documented
• Ensuring adherence to all organizational and external regulatory requirements
• Development, implementation and maintenance of a robust and fully compliant quality system in accordance with ISO 13485
• Liaise with external agencies for MDR approvals and support FDA approval applications and engagements
• Support technical product verification and validation
• Approving products for release to clients
• Delivering research strategy and initiatives under guidance of CSO
• Conducting internal audits and leading annual external audits
• Be an advocate for the patient's safety and quality delivery at all times
• Create a strong team working environment with a focus on delivery and quality assurance

What we offer

• Part Time Role on Fixed Contract
• Work with a
  - driven team dedicated to transforming the lives of people with neurological conditions through technology
• Healthcare Insurance Credit
• Remote work with an opportunity to meet with the team in person to collaborate on project scoping and product workshops