Quality Engineer II - Product Surveillance
Location: Tampa, Florida
Working Situation: 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 II, Product Surveillance to join our esteemed global medical device company, celebrated for its groundbreaking advancements in product development. As a pivotal member of our team, you will drive product improvements by performing and supporting Product Quality Complaint evaluations and investigations, analyzing and trending Product Quality Complaint data, and providing timely customer feedback to key stakeholders. If you have a passion for excellence and a drive to make impactful contributions in the industry, we want to hear from you!
The Quality Engineer II, Product Surveillance will be responsible for:
- Developing and promoting the Product Surveillance processes for medical devices, including creating and managing global policies and procedures.
- Performing root cause analysis for returned complaint devices or identified trends.
- 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.
- Providing timely customer feedback to key stakeholders 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 II, Product Surveillance will have the following qualifications:
- Bachelor's degree in Engineering or Engineering Technology required.
- Minimum of 2 years' experience with root cause analysis, project management, and continuous improvement in a regulated environment.
If you are interested in the Quality Engineer II, Product Surveillance position, apply now!
