Quality Engineer I, Post-Market Surveillance
JBL ResourcesCovington, GA
Automate your job search with Sonara.
Submit 10x as many applications with less effort than one manual application.1
Reclaim your time by letting our AI handle the grunt work of job searching.
We continuously scan millions of openings to find your top matches.
Overview
Remote
On-site
Job Description
Post-Market Surveillance Quality EngineerLocation: Greater Atlanta AreaAbout Our Client: Our client is a highly respected organization within the manufacturing industry, recognized for delivering innovative, high-quality solutions to a global customer base. They are committed to operational excellence and continuous improvement, leveraging advanced technologies to remain competitive and forward-thinking. With a collaborative, performance-driven culture, the company empowers employees to take ownership of their work while supporting professional growth and long-term career development. This is an excellent opportunity to join a stable, reputable organization that values integrity, quality, and its people.Key Responsibilities:
- Leading and managing Post-Market Surveillance (PMS) activities, ensuring all reviews are completed on time and in compliance with applicable regulations, quality standards, and company procedures.*
- Developing and maintaining Post-Market Surveillance Plans and Reports.*
- Gathering data from multiple internal and external sources*
- Analyzing product performance and safety information*
- Documenting post-market findings accurately*
- Preparing clear summaries, conclusions, and recommendations*
- Identifying gaps, trends, and opportunities through PMS reviews and driving updates to product documentation as needed.*
- Supporting and implementing improvements to PMS processes, procedures, practices, and related documentation.*
- Partnering closely with Quality, Regulatory Affairs, R&D, Clinical Affairs, Marketing, and Operations teams to ensure the timely completion of PMS activities and reviews.
- Bachelors degree in Engineering, Science, or Mathematics.*
- 1-3 years of experience in Post-Market Surveillance within the medical device industry.*
- Proficiency in generating detailed reports and analyzing data to extract meaningful insights.*
- Strong problem-solving, analytical, and conceptual thinking skills.*
- Excellent communication skills, with the ability to effectively listen, question, and collaborate.*
- Ability to manage multiple projects simultaneously in a dynamic environment.*
- Fundamental understanding of product risk management tools such as FMEAs, Risk Management Plans, and Benefit-Risk Analyses.*
- Knowledge of global regulations like ISO 13485:2016, FDA QSR, EU MDR 2017/745, and ISO 14971:2019.*
- Basic statistical knowledge and understanding of risk management processes.*
- NO C2C CANDIDATES
Automate your job search with Sonara.
Submit 10x as many applications with less effort than one manual application.
FAQs About Quality Engineer I, Post-Market Surveillance Jobs at JBL Resources
What is the work location for this position at JBL Resources?
This job at JBL Resources is located in Covington, GA, according to the details provided by the employer. Some roles may also include multiple work locations depending on the requirement.
What pay range can candidates expect for this role at JBL Resources?
Employer has not shared pay details for this role.
What employment applies to this position at JBL Resources?
The employer has not provided this information. This may be discussed during the hiring process.
What is the process to apply for this position at JBL Resources?
You can apply for this role at JBL Resources either through Sonara's automated application system, which helps you submit applications 10X faster with minimal effort, or by applying manually using the direct link on the job page.