Quality Assurance Manager

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 co-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 quality-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 mission-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