A medical device
start-up looking to hire a QA RA Manager who will support the product
development of a cutting edge structural heart device through design
development, verification, clinical trials, validation and regulatory approval.
This position offers the opportunity to join the management team in an exciting
early stage company.
Role and responsibilities:
ownership of the QA and RA functions at CroiValve encompassing all activities
leading to commercial approval.
Development, implementation and maintenance of a
robust and fully compliant quality system in accordance with ISO 13485,
including risk management
Continuous improvement of the QMS to meet the
requirements of all stakeholders
Manage supplier evaluations and audits
Ensure product quality requirements are met both
internally and throughout the supply chain during product manufacturing.
Support product verification and validation, including
risk management, bio-compatibility testing (ISO 10993), microbiological
(disinfection) validation and clinical evaluation
Act as the primary point of contact with Regulatory
authorities and the Notified Body to ensure the company’s activities are
aligned to their requirements
Manage all quality related activities for device manufacturing
ensuring effective and efficient controls are implemented and maintained
(inspection standards, plans, frequencies and test methods).
Develop and manage a high-performance quality
engineering team. Create a strong team working environment with focus on
compliance, product quality, and risk mitigation.
Manage Quality System audit processes
Provide training to company employees in relevant
areas of the quality system
actions of global regulatory agencies to stay current with requirements and
degree in science, engineering or related field
track record in a similar role with a minimum of 8 years in medical device
quality systems or equivalent
current understanding of FDA and ISO requirements, with the ability to
interpret these requirements and implement them into a lean compliant product
knowledge of the EU Medical Device Directive and MEDDEV guidance documents
in design, verification and process validation processes
experience and knowledge in GMP, process validation, change control, CAPA and
electronic document control systems
experience in class III medical products highly preferred
experience in a medical device start up preferred.
leadership and project management skills with the ability and willingness to
effectively build and manage a small team. Experience in people management and
verbal and written communication skills
working with sub-contract manufacturers/suppliers, including integration of
quality management systems.
device CA/RA/QA/QC management experience with quantifiable record of
achievement with an ability to analyse and challenge data, identify and address
gaps, and generate technical reports to support submissions
qualities. Entrepreneurial team player
in a start-up business, can adapt (in the absence of previous experience) to a
small company environment.
flexible, collaborative, and proactive; a team leader who can positively impact
both strategically and tactically.
communication skills; ability to influence & engage team members, executive
peers and representatives of major international regulatory bodies. They will be a credible voice of authority in
representing the company with such bodies.