Job

QA Specialist €60-80K

Great opportunity for a QA professional to join a medical device start-up who are ISO 13485 certified and have attained CE Markings for their products to help set up and maintain a QMS and manage documentation. This role gives you the opportunity to hone your QA skills and help the company work towards releasing their upcoming new products and the R&D. You will also be responsible for engaging with the medical device regulator.

The company have big growth plans with current operations in the middle east and plan to enter new markets in Europe, The Middle East and Asia within the coming 12 months.

What's in it for you?

• Salary: €60-80K (Fulltime or part-time (pro-rata)) based on the level of experience
• Job Type: Full-time permanent or part-time
• Location: Ireland (100% remote, but company is based in Dublin)
• Remote Working: 100 percent remote working- candidates should be based in Ireland
• Benefits: such as pension, healthcare
• Opportunity to play a key role in a medical device start-up who are destined for major growth

What would your responsibilities look like?

• To create and maintain the necessary documentation for the ISO 13485 and Quality Assurance Manual
• Set up and maintain the Quality Management System (QMS).
• To establish & maintain all aspects of the EU MDR technical files and audit requirements.
• To manage a close working relationship with regulators and the notified bodies and later to be involved in regulatory affairs.
• To carry out product-related regulatory submissions in the EU and other territories where the products are sold

Your background

• Engineering/Science degree qualification with 3+ years of working experience within a medical device environment in a similar capacity.
• Good technical writing experience within a medical device environment.
• Knowledge of Quality and Regulatory requirements and regulations including but not limited to ISO 13485 Quality System requirements, Council Directive 93/42/EEC (Medical Device Directive), MEDDEV.
• Ability to work under pressure and deadlines and who can give attention to detail and accuracy.

What's Next?
If you are looking for work life balance and a full-time/ part-time Quality role, then this QA specialist role may be a good fit. To be considered for this role apply now with CV. You can also reach out with your LinkedIn profile to Som in Principle. All CVs/profiles are reviewed in the strictest confidence.

For more info contact Som Rajendra Email: som@principlehr.com | 016035075