QA Associate (Entry-Level)

Dosimetry, LLC; Maryland; Remote; USD 50,000 - 70,000; Full time

Job summary

A leading company in medical device manufacturing is seeking an Entry-Level Quality Assurance (QA) Associate. This remote position focuses on managing quality systems and ensuring compliance with regulatory standards. Ideal candidates will have experience in QA, strong analytical skills, and a proactive mindset to support innovations in cancer treatment.

Qualifications

• 1-3 years of experience in quality assurance with medical devices.
• Knowledge of ISO 13485:2016 and 21 CFR Part 820.
• Ability to interpret standards and regulations.

Responsibilities

• Manage document control and maintain external documents.
• Oversee training processes and maintain quality standards.
• Assist in audit preparations and conduct supplier assessments.

Skills

Analytical skills

Problem-solving

Attention to detail

Communication skills

Time management

Teamwork

Tools

Microsoft Word

Microsoft Excel

Microsoft Outlook

Microsoft Teams

Microsoft PowerPoint

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 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 to make cancer curable by providing simplified and standardized dosimetry. We focus on state-of-the-art quantitative imaging and dosimetry services and software products for radiopharmaceuticals. As a QA Associate at Rapid, you'll ensure our SaMD products meet the highest standards, contributing directly to our vision of leading in radiation delivery tools. And the best part? We're doing it all 100% remotely, so you can contribute from your own space!

Your Mission:

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

Duties and Responsibilities:

• Manage document control and maintain documents of external origins, assist employees with change requests, review change requests, and monitor periodic reviews.
• Handle and maintain all Quality training, including creating and maintaining training events.
• Review, analyze, and approve suppliers for Rapid’s Approved Supplier List (ASL), maintaining the list and conducting supplier assessments.
• Review and analyze feedback.
• Manage non-product-related nonconformances, working with departments on investigations, root cause analysis, risk assessment, and timely closure.
• Oversee employee onboarding and offboarding processes.
• Assist in audit preparations and record meeting minutes.
• Develop and revise standard operating procedures and work instructions.
• Track trends and analyze data to inform decisions.
• Perform additional duties as assigned.

Qualifications:

• 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.
• Ability to interpret and communicate applicable standards and regulations.
• Proficiency 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 skills.
• Effective oral and written communication and interpersonal skills.
• Proactive mindset with the ability to recognize opportunities for improvement and implement solutions.
• Strong teamwork skills, with the ability to work independently and remotely.