Quality Assurance associate

We are seeking a seeking a Quality Assurance Associate to join our dynamic team at our Manufacturing Facility located in Dublin, where we manufacture sample collection kits. In this role, you'll be at the forefront of ensuring product integrity through conducting thorough quality inspection activities, including visual inspections, dimensional measurements, and material testing.

Responsibilities include, but are not limited to, the following:

• Ensuring the quality of sample collection kits by following relevant procedures, conducting incoming inspections of raw materials to confirm they meet specifications and acceptance criteria.
• Prior to product release, reviewing batch paperwork and maintaining compliant documentation and records according to site procedures for record control.
• Promptly notifying management of any product quality issues, documenting on-hold notices and quality alerts efficiently, and participating in continuous improvement projects and initiatives at the site.
• Supporting applicable processes within the Quality Management System (such as Change Controls, Documentation Management, CAPAs/NCRs, Audit Readiness, and Supplier Quality Management).
• Assisting management in compiling and presenting daily and weekly Quality metrics.

What are we looking for?

• A Bachelor's degree, preferably in Science, Quality, Engineering, or a related field, with 1-2 years of experience in the quality assurance department of the medical device or pharmaceutical industry.
• Demonstrates keen attention to detail and capable of managing multiple conflicting priorities with minimal supervision and timely escalation of identified issues to management.
• Strong communication skills, both written and verbal, along with exceptional organizational abilities.
• Proficient technical comprehension, capable of understanding and executing steps outlined in relevant procedures.
• Exceptional troubleshooting, analytical, problem-solving, and root-cause analysis skills.
• Ability to emphasize the importance of ensuring product quality and compliance with regulations.
• Possesses a basic understanding of ISO 13485:2016, FDA 21 CFR Part 820, and other applicable regulations.

Benefits: 

Alongside base salary of €32,000 - €35,000, we offer a range of benefits including: 

• Health insurance and an Employee Assistance Programme 
• Pension matching contribution
• Annual Compensation Reviews 
• After 90 days you will be eligible to avail of Flexible Annual Leave where you are not restricted to a specific number of holiday days/annual leave
• Free monthly LetsGetChecked tests as we are not only focused on the well being of our patients but also the well being of our teams
• A referral bonus programme to reward you for helping us hire the best talent
• Internal Opportunities and Careers Clinics to help you progress your career within the company.  
• Bike to work scheme - and secure bike storage onsite. 
• Maternity, Paternity, Parental and Wedding leave.