QA/RA Manager Job Specification

Opportunity

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:

  • Take 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
  • Monitor actions of global regulatory agencies to stay current with requirements and changes.
  • Member of leadership team.

Requirements:

  • Bachelor degree in science, engineering or related field
  • Proven track record in a similar role with a minimum of 8 years in medical device quality systems or equivalent
  • Deep and current understanding of FDA and ISO requirements, with the ability to interpret these requirements and implement them into a lean compliant product
  • In depth knowledge of the EU Medical Device Directive and MEDDEV guidance documents
  • Experience in design, verification and process validation processes
  • Prior experience and knowledge in GMP, process validation, change control, CAPA and electronic document control systems
  • Prior experience in class III medical products highly preferred
  • Prior experience in a medical device start up preferred.
  • Good leadership and project management skills with the ability and willingness to effectively build and manage a small team. Experience in people management and development.
  • Excellent verbal and written communication skills
  • Experience working with sub-contract manufacturers/suppliers, including integration of quality management systems.
  • Medical 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

Personal Attributes

  •  Leadership qualities. Entrepreneurial team player
  • Comfortable in a start-up business, can adapt (in the absence of previous experience) to a small company environment.
  • Energetic, flexible, collaborative, and proactive; a team leader who can positively impact both strategically and tactically.
  • Superior 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.
  • Detail and results oriented.

Availability to travel is required