Quality Assurance Associate

LetsGetChecked is a global healthcare solutions company that provides the tools to manage health from home through health testing, virtual care, genetic sequencing, and medication delivery for a wide range of health and wellness conditions. LetsGetChecked's end-to-end model includes manufacturing, logistics, lab analysis, physician support, and prescription fulfillment. Founded in 2015 and co-headquartered in Dublin and Atlanta, LetsGetChecked empowers people to take control of their health and live longer, happier lives.

Quality Assurance Associate

We are seeking a Quality Assurance Associate to join our team in the manufacturing facility located in Dublin. In this role, you'll be responsible for ensuring product integrity through conducting thorough quality inspection activities, including visual inspections, and dimensional measurements while maintaining strict adherence to the organization’s Quality Management System (QMS) procedures and ensuring full compliance with ISO 13485 and applicable regulatory requirements, including the EUMedical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).

Responsibilities

• Ensuring the quality of products by following relevant procedures, conducting incoming inspections of raw materials to confirm they meet specifications and acceptance criteria.

• Prior to product release, reviewing batch records and maintaining compliant documentation 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 initiatives at the site.

• Supporting applicable processes within the Quality Management System (such as Change Controls, Documentation Management, CAPAs/NCRs, Audits, and Supplier Quality Management).

• Assisting management in compiling and presenting daily and weekly Quality metrics.

What we are looking for…..

• A bachelor’s degree, preferably in Science, Quality, Engineering, or a related field, with 1-2 years of experience within the quality assurance team in a 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.

• Basic understanding of ISO 13485, FDA 21 CFR Part 820, EU-MDR, and EU-IVDR and other applicable regulations.

Benefits:

Alongside base salary of €31,000 - €33,000, we offer a range of benefits including:

• Health insurance and an Employee Assistance Programme

• Pension matching contribution

• Annual Compensation Reviews

• LetsGetChecked has a flexible annual leave policy

• 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.

Why LetsGetChecked

At LetsGetChecked, we are revolutionizing healthcare by making it more accessible, convenient, and personalized. Our mission is to empower individuals with the knowledge and tools they need to manage their health proactively, so they can live longer, happier lives.

By joining our team, you will be part of a dynamic and innovative company that is dedicated to improving lives through cutting-edge technology and compassionate care. We value our employees and invest in their growth, offering opportunities for professional development and career advancement. Together, we can make a meaningful impact on the future of healthcare and help people take control of their health journey. Join us in our commitment to transforming healthcare for the better.

Our Commitment to Diversity, Equity, and Inclusion

At LetsGetChecked, we are committed to fostering an inclusive environment that celebrates diversity in all its forms. We believe that the diversity of thought, background, and experience strengthens our teams and drives innovation. We are an equal-opportunity employer and do not discriminate on the basis of race, ethnicity, religion, color, place of birth, sex, gender identity or expression, sexual orientation, age, marital status, military service status, or disability status. Our goal is to ensure that everyone feels valued and empowered to thrive. Please review our Candidate Privacy Policy.

To learn more about LetsGetChecked and our mission to help people live longer, healthier lives please visit https://www.letsgetchecked.com/careers/