Quality Engineer - Field Safety Corrective Action (FSCA)
Location: Atlanta, GA
Working Schedule: Onsite
Join a world leader in medical device innovation, transforming surgical care and improving patients' lives globally. The commitment to cutting-edge research and compassionate healthcare solutions ensures that every day brings new challenges and opportunities for growth. Be part of a team where your expertise and passion will drive impactful advancements in medical technology.
We are seeking a Quality Engineer - Field Safety Corrective Action (FSCA) to join our esteemed global medical device company. This role is pivotal in driving product improvements by performing and supporting product quality complaint evaluations and field safety communications. If you have a Bachelor's degree in Engineering and over 2 years of experience in root cause analysis, project management, and continuous improvement in a regulated environment, we want to hear from you.
The Quality Engineer - Field Safety Corrective Action (FSCA) will be responsible for:
- Developing and managing global policies and procedures for Product Surveillance processes for medical devices.
- Conducting root cause analysis for returned complaint devices or identified trends as needed.
- Maintaining test protocols to evaluate returned products according to established specifications and recording detailed results.
- Collaborating with Design Engineering, Manufacturing Engineering, Product Management, and Quality Engineering teams to drive continuous process and product improvement.
- Acting as the global representative for complaint investigation, escalation, and trending processes during Agency/3rd Party Audits and assisting in the preparation and submission of audit responses and requests for information to regulatory bodies such as the FDA and Notified Bodies.
- Providing timely customer feedback through root cause analysis, statistical analysis, and regular forums.
- Supporting global complaint triage, intake, evaluation, reporting, investigation, closure, and trending activities.
- Managing supplier relationships from initial notification to receipt of supplier complaint evaluations.
The Quality Engineer - Field Safety Corrective Action (FSCA) will have the following qualifications:
- Bachelor's degree in Engineering or Engineering Technology.
- Over 2 years of experience in root cause analysis, project management, and continuous improvement in a regulated environment.
If you are interested in the Quality Engineer - Field Safety Corrective Action (FSCA) position, apply now!
