Job Title: Quality Assurance Manager
Are you an Experienced Quality Assurance professional with Management experience? An Exciting Opportunity has arisen with our Clients Medical Device Company in Dublin. The client's trajectory is developing fast and offers the opportunity for the right candidate to go far with their career from joining the team at the early stages of the company. The Ideal candidate will have experience in design development, verification, clinical trials, validation, and regulatory approval while demonstrating excellent leadership skills in their current or past roles.
- 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, ensuring processes are lean, compliant, user-friendly and are well understood throughout the organisation.
- Manage Quality System audit processes, including supplier evaluations and audits.
- Provide training to company employees in relevant areas of the Quality System.
- Manage all Quality related activities for device manufacturing ensuring effective and efficient controls are implemented and maintained (inspection standards, plans, frequencies and test methods).
- Ensure product quality requirements are met both internally and throughout the supply chain during product manufacturing.
- Support product verification and validation, including risk management, biocompatibility testing (ISO 10993), microbiological (disinfection) validation, pre-clinical and clinical evaluations.
- Ensure activities are conducted in compliance with the regulations and standards applicable to the product.
- Strong project management skills to lead cross functional projects, ensuring on time and on budget delivery. Creative approaches to reducing project risks and shortening timelines while delivering business objectives.
- Demonstrate collaborative leadership, being able to collaborate across multiple functions, beyond Quality.
- 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 external vendors/partners as necessary to support Quality activities.
- Ensure interactions with colleagues/stakeholders fully reflects the company values
- Bachelor's degree in science, engineering, or related field
- Minimum of eight (8) years in a similar role in medical device quality systems or equivalent
- Deep and current understanding of FDA and ISO 13485 requirements, with the ability to interpret these requirements and implement them into a lean compliant product.
- 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 implantable devices required.
- Experience working with sub-contract manufacturers/suppliers, including integration of quality management systems.
- Medical device 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.
- Good problem-solving mindset
- 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.
- Strong verbal and written communication skills
- At ease in start-up environment and effectiveness to deliver in low-structured environments.
Availability to travel is required.
The above role profile is not designed to cover a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities, and activities may change, or new ones may be assigned from time to time.
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As an Equal Opportunities employer we welcome applications from all suitably qualified persons regardless of their race, sex, disability, religion/belief, sexual orientation or age.