LetsGetChecked is a leading at-home health testing company, with a platform that allows consumers to discover and access personalized health information conveniently, confidentially and accurately. We empower people to take an active role in their health to live longer, happier lives. LetsGetChecked was founded in 2015 and has corporate offices located in New York City and Dublin.

Reporting to the Quality Manager in our Dublin manufacturing facility where we assemble our sample collection kits, the main duties of the Quality Engineer will be

Job Responsibilities:

Quality Assurance support for all products manufactured, assembled and distributed within the organization.
Maintain Quality Management System compliance with ISO13485, (EU) 2017/745, 2017/746, 21CFR Part 820 and applicable Good Manufacturing Practice regulations within the company.
Manage improvement projects as they are assigned.
Participate in supplier qualification and monitoring for new and existing products including auditing.
Liaise with external parties on requirement to support quality assurance and regulatory activities.
Provides quality support in the resolution of complaints investigation, CAPAs, regulatory requirement changes.
Manages a dynamic Risk Management process for all processes within the Let’s Get Checked Organization
Updates Quality policies to ensure compliance with quality system needs and relay this information where required.
Manage the inspection of raw materials and components to ensure that they meet specification and are suitable for use and work effectively on manufacturing quality assurance activities.
Responsible for managing and working on CAPA/NCR, Deviations, Quality Alerts, Supplier Qualification, On-Hold notices, Design assurance activities etc. as applicable.
Responsible for customer complaint handling and maintenance of the customer complaint handling system including the implementation and follow up of corrective actions
Support all validation activities within the organization in line with GAMP5 methodologies.
Ensure effective investigation and assessment of quality issues e.g. non-conformance and CAPA and productivity initiatives associated with operations
Document validation protocols and reports as required.

What we're looking for:

Bachelor's/Master’s degree preferably in Quality, Biomedical Engineering or related field with 2-3 years of experience in quality department in a medical device industry.
Good working knowledge of ISO13485, (EU) 2017/745, 2017/746 and 21CFR820
Ability to work independently and as a member of a cross-functional team, to multi-task and prioritise to meet high expectations and tight deadlines
Lead auditor or qualified internal auditor would be essential.
Good technical capabilities, communication skills, teamwork abilities and initiative.
System driven with good attention to detail during daily routine.
Proven ability to work well as part of a team & on own with minimum supervision
Good team member, fully motivated to achieve and demonstrate best practices in line with the project, department and site objectives
Excellent analytical and problem-solving abilities.
Experience in validation techniques, risk management, statistical techniques and compliance to regulatory requirements.
Proficiency in the areas of managing and working on CAPA/NCR, Deviations, Quality Alerts, Supplier Qualification, On-Hold notices, Design assurance activities etc. as applicable.
Must be available to travel on requirement - 10%.

Why LetsGetChecked?

Together we have a common goal to help people live longer, happier lives.

We want our employees to be healthy, travel often, and have the financial resources and support they need to live a fulfilling life, both inside and outside of work. We encourage our employees to build their careers at LetsGetChecked. We run regular career training clinics, interview assistance, and encourage employees to apply for internal opportunities. We support Learning & Development through our partner Udemy.

Diversity, Equity & Inclusion:

As we continue to grow, LetsGetChecked is fully committed to creating an inclusive environment where diverse backgrounds, perspectives and experiences are valued, where each and every one of our people feels that they belong and are empowered to do the best work of their career.

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