Quality Engineer: Medical Device Complaints & Investigations

Suru; Baltimore (MD); On-site; USD 70,000 - 90,000; Full time

Job summary

A medical device company is seeking a Quality Engineer to manage complaint handling and technical investigations. Responsibilities include troubleshooting escalated cases, conducting investigations, and ensuring compliance with medical device regulations. Ideal candidates will have a Bachelor’s degree in Engineering or a scientific discipline and 1–2 years of relevant experience in a GMP environment. Strong problem-solving and technical writing skills are essential.

Qualifications

• 1–2 years of experience in medical device complaint handling or quality engineering.
• Familiarity with regulations including ISO 13485 and EU MDR.
• Experience in a GMP and/or ISO-regulated environment.

Responsibilities

• Troubleshoot escalated cases from Customer Service and provide timely feedback.
• Support complaint processing and conduct investigations.
• Perform failure analysis of returned devices and identify root causes.

Skills

Problem-solving skills

Communication of technical findings

Technical writing skills

Troubleshooting skills

Education

Bachelor’s degree in Engineering or a Scientific discipline

Tools

MS Office (Outlook, Word, Excel, PowerPoint)

Job description

A medical device company is seeking a Quality Engineer to manage complaint handling and technical investigations. Responsibilities include troubleshooting escalated cases, conducting investigations, and ensuring compliance with medical device regulations. Ideal candidates will have a Bachelor’s degree in Engineering or a scientific discipline and 1–2 years of relevant experience in a GMP environment. Strong problem-solving and technical writing skills are essential.