Quality Engineer I, Post-Market Surveillance

Post-Market Surveillance – Quality Engineer
Location: Greater Atlanta Area
About 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.

Qualifications:

• Bachelor’s 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

Interested Candidates please apply on our website at https://jobs.jblresources.com.
For more information about our services and great opportunities at JBL Resources, please visit our website: https://www.jblresources.com.
JBL Resources is proud to have earned the reputation of being a premier provider of top talent professionals in the fields of engineering, human resources, logistics, operations, and supply chain management. As specialists in both permanent placement and contract services, our mission is to help companies and individuals become all they were created to be.
**JBL is an Equal Opportunity Employer and E-Verify Company