Product Surveillance Quality Assurance Specialist

7 days ago

Tampa, Florida, United States DSJ Global Full time
DSJ Global Product Surveillance Quality Assurance Specialist

We are seeking a highly skilled Product Surveillance Quality Assurance Specialist to join our global medical device company. As a key member of our team, you will play a vital role in driving product improvements by performing and supporting Product Quality Complaint evaluations and investigations.

The successful candidate will have a strong background in quality engineering, with a minimum of 2 years' experience in a regulated environment. They will be responsible for developing and promoting Product Surveillance processes for medical devices, including creating and managing global policies and procedures.

The ideal candidate will possess excellent analytical and problem-solving skills, with the ability to perform root cause analysis for returned complaint devices or identified trends. They will also be able to maintain test protocols to evaluate returned products according to established specifications and record detailed results.

This is an exciting opportunity to work with a world leader in medical device innovation, transforming surgical care and improving patients' lives globally. If you are passionate about quality and excellence, and have a drive to make impactful contributions in the industry, we encourage you to apply.

Key Responsibilities:
  • Develop and promote Product Surveillance processes for medical devices, including creating and managing global policies and procedures.
  • Perform root cause analysis for returned complaint devices or identified trends.
  • Maintain test protocols to evaluate returned products according to established specifications and record detailed results.
  • Collaborate with Design Engineering, Manufacturing Engineering, Product Management, and Quality Engineering teams to drive continuous process and product improvement.
  • Act as the global representative for complaint investigation, escalation, and trending processes during Agency/3rd Party Audits, and assist in the preparation and submission of audit responses and requests for information to regulatory bodies.
Requirements:
  • 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.

The estimated salary for this position is $85,000 - $110,000 per year, based on location and experience. This is a competitive offer that reflects the value we place on your skills and qualifications.

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