Innovative, rapidly growing medical device company based in Dublin has a great opportunity for ambitious, hard-working, hands-on and passionate, Quality leader to join the team and shape product roadmaps and development plans while also contribute to the company’s strategy and culture.
Role will be adapted/ evolved depending on the experience and future career aspirations of any potentially interested candidates. Ultimately, seeking an individual to own the Quality function and grow with the company. Recent regulatory experience would advantageous but not essential. Role is full-time – but open to considering reduced hours for strong candidates.
Send CV to: firstname.lastname@example.org
Objectives of role:
• Lead QMS activities, driving the development and execution of related objectives
• Liaise with external Quality consultants to tailor the QMS to ensure it is fit for purpose
• Act as the owner of the QMS, specifically the Design History File for FIRE1’s new product, and work with the internal team and suppliers to ensure quality at the core of all activities
• Provide Quality input into overall programme management
• Participate in cross functional product development
• Investigate and resolve Quality issues in a timely manner in conjunction with all relevant stakeholders.
• Work with the Engineering team to monitor and enhance quality performance and capability in line with the developing needs of the business
• Bachelor’s/ Master’s degree in Engineering, Science, or related field
• 5+ years’ experience in medical device quality/ product development role
– Ideally in implanted devices
– Potentially with some medical electronics experience/ exposure
• Strong communication and influencing skills – good listener
• Ability to work under pressure and meet deadlines
• Target driven individual who can work to own initiative
• Knowledge of quality systems and principles, especially ISO13485
• Skilled in statistical methods
• Six-sigma / lean experience