Descripción: Position offer:
Full time position (40 hours/week)
Gross annual salary commensurate with experience.
Temporary contract (2yrs), option for permanent position
– Bachelor’s or advanced degree in Health Sciences, Engineering or similar.
– Practical experience in developing FDA 510 (k) and CE Marking submissions (Regulation (EU) 2017/745)
– 5 or more years of experience in Quality Management System in accordance with ISO 13485: 2016 and 21 CFR Part 820
– 5 or more years of experience in related medical devices, pharmaceutical, or healthcare industries
– Technical writing skills
– Project management skills
– Ability to lead a cross-functional team
– Advanced verbal and written English
– Minimum of 2 years experience as an internal auditor.
– Minimum of 2 years experience in management positions in Quality Management area, if possible in healthcare sector.
Your responsibilities will be to implement, monitor and maintain a Quality Management System according to the ISO 13485:2016 and 21 CFR Part 820 at a research oriented SME and to support the transition to a certified medical device manufacturer:
– Prepare documentation for 510(k) submission, CE mark and any other licensing
– Maintain the status of FDA Title 21 CFR Part 820 and ISO 13485 (Quality Management System for Medical Devices)
– Lead the internal/ external audits and interact with authority, consultants, or auditors
– Coordinate corrective actions of problems on quality management and resolve non-conformance
– Assure complaints from customers or internal users to be solved and follow the reporting procedures to authorities
– Conduct internal training required by the regulations
– Create quality metrics to evaluate and monitor the effectiveness of the quality system
– Define and update (when appropriate) the Company´s Process Map, in collaboration with the management.
– Define Key Performance Indicators (KPIs).
– Propose, monitor and evaluate the annual quality objectives of the company.
– Appoint the internal audit team, prepare and approve the annual audit plan.
– Approve and audit suppliers and subcontractors (current and potential) according to the established audit plan.
– Assume responsibility for document management of the company: creation of document structures (definition of files / folders on paper and computer support) and standardization of document management in all departments.
– Follow-up contacts with Notified Bodies.
HemoPhotonics S.L. is a leader in diffuse correlation spectroscopy (DCS) to monitor blood flow in the microvasculature of tissue, which is reflected in the development of the first DCS blood flow neuromonitor research device. Moreover, the company is expanding its development pipeline by incorporating different diagnostic techniques into hybrid devices as a result of strategic alliances with academic and industrial partners. Leveraging these skills and expertise, we intend to translate novel optical technologies into commercial medical devices for non-invasive monitoring of hemodynamic parameters and to deliver cutting-edge research medical devices with the ultimate goal of improving patient care.
HemoPhotonics S.L. is proud to be an equal opportunity employer.
All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, disability or age.
Tecnologías: ISO 13485, FDA Title 21 CFR Part 820
Tipo de Contrato:
Salario: Sin especificar
Experiencia: Más de 5 años
Funciones: Auditor – Responsable de Producto – Sistemas de Calidad