Current Health

The Product and Technology Quality Manager plays a critical role in ensuring the quality, safety, and compliance of our medical device products and technology solutions. This role involves managing all quality processes related to development, supporting product development teams (product &amp; engineering) in understanding and implementing compliant processes, ensuring documentation is maintained by teams, that testing and validation is completed and appropriate documentation is maintained. This person will be collaborating with all teams involved in development, including customer, clinical, product and engineering (SWE &amp; HWE) to drive compliance and continuous improvement. Key Duties &amp; ResponsibilitiesTechnology Quality Assurance:Collaborate with and enable the product and technology development teams to implement quality assurance practices for software and hardware components of medical devices. This role requires a primary focus on Software Engineering including Software as a Medical Device inc. the use of Agile practices in a regulated environment.Quality Management &amp; Compliance:Develop, implement, and maintain appropriate processes to support the development of the Current Health systems and ensure compliance with those systems. Work closely with product, engineering, and manufacturing teams to address quality issues and drive corrective and preventive actions to improve processes and outputs. Ensuring the outputs of the development process can be used for regulatory submissions and that documentation maintained by the teams is audit ready at all times.Regulatory Compliance:Stay updated with medical device software development regulations, standards, guidances and state of art medical device development practices, ensuring that products and technology solutions align with these requirements.Training:Provide expert knowledge and input into the teams, providing training and mentoring on compliant processes and regulatory requirements.Product Testing and Validation:Provide input into the testing, verification and validation activities as needed to ensure products meet design specifications and performance criteria. Risk Management:Collaborate with the risk management, product and engineering teams to ensure risk management activities are undertaken at appropriate stages and managed and documented in accordance with compliant processes.RequirementsEssential Requirements, Qualifications &amp; Experience<ul> <li>Minimum of 5 years of experience in product development roles (project management, quality management working across hardware and software products</li> <li>Strong knowledge of medical device regulations and standards (e.g., FDA 21 CFR, ISO 13485) in relation to development activities</li> <li>Experience with quality management software and tools.</li> <li>Familiarity with software quality assurance practices for medical device software.</li> <li>Excellent leadership, communication, and problem-solving skills.</li> <li>Detail-oriented with a commitment to maintaining the highest standards of quality and compliance.</li> <li>Ability to collaborate effectively across departments and with external stakeholders.</li> </ul>Desired Requirements<ul><li>Bachelor's degree in a relevant scientific or engineering field.</li></ul>Benefits<ul> <li>Pension Plans</li> <li>Work From Home</li> <li>Employee Assistance Programme - Counseling</li> <li>Life Assurance</li> <li>Leave Package</li> <li>Training &amp; Development</li> </ul>