QA Associate (Entry-Level)

Job Description

Entry-Level Quality Assurance (QA) Associate Wanted:

This is an exciting entry-level opportunity to grow your career while making a meaningful impact. Are you passionate about making a difference in the fight against cancer? Are you ready to be part of a groundbreaking startup that's reshaping the landscape of cancer treatment? Then look no further! Radiopharmaceutical Imaging and Dosimetry (Rapid), LLC is looking for a motivated Quality Assurance (QA) Associate to join our Quality Department. Rapid is not just a company; we’re a movement. Based in the city of Baltimore, MD, we are a software as a medical device (SaMD) manufacturer with a vision to become the premier provider of tools for smart delivery of radiation.

About Us:

As a fast-growing startup, we are looking for passionate individuals eager to learn, adapt, and contribute to our mission. Our mission is clear - to make cancer curable by providing simplified and standardized dosimetry. We are focused on providing state-of-the-art quantitative imaging and dosimetry services and software products for radiopharmaceuticals. As a QA Associate at Rapid, you'll be at the forefront of ensuring that our SaMD products maintain the highest standards, contributing directly to our vision of becoming the premier provider of tools for smart delivery of radiation. And the best part? We're doing it all 100% remotely, so you can contribute to our cause from the comfort of your own space!Your Mission:

The QA Associate plays a critical role in managing and maintaining the Quality Management System (QMS) within the Quality Assurance and Regulatory Affairs (QA/RA) Department. This position ensures compliance with applicable quality standards and regulatory requirements, focusing on QMS administration, documentation control, and post-market surveillance to uphold the integrity and safety of medical devices.

Duties and Responsibilities:

Responsible for document control and maintaining documents of external origins. This includes assisting employees with the creation of change requests and/or assisting in reviewing change requests prior to routing for approval, and monitoring periodic reviews.

Responsible for handling and maintaining all Quality training, including creating and maintaining all quality training events.

Responsible for supplier management by reviewing, analyzing, and approving suppliers for Rapid’s Approved Supplier List (ASL). This includes maintaining the ASL and ensuring supplier assessments are performed.

Responsible for reviewing and analyzing feedback.

Responsible for non-product-related nonconformances. This includes working with other departments on investigations, root cause analysis, risk, and actions for NCs, and ensuring timely closure.

Overseeing employee onboarding/offboarding.

Assist with the preparation of audits and take meeting minutes.

Assist with the development and revisions of standard operating procedures and work instructions.

Tracking trends and providing data analysis.

Perform other duties as assigned.Qualifications:

Must have a minimum of 1-3 years of quality assurance experience with medical devices.

Strong knowledge of ISO 13485:2016 and 21 CFR Part 820.

Growing knowledge of EU MDR 2017/745.

The ability to interpret and communicate applicable standards/regulations.

Proficient in Microsoft Word, Excel, Outlook, and Teams. PowerPoint is a plus.

Excellent analytical, problem-solving, and decision-making skills.

High attention to detail with strong time management and organizational abilities.

Effective communication (oral and written) and interpersonal skills.

Proactive mindset, capable of recognizing opportunities for improvement and implementing effective solutions.

Strong teamwork orientation with the ability to work independently and in a remote environment.

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Full-time