Quality Complaints Engineer II – Medical Devices

Terumo Cardiovascular Group; Town of Florida (NY); On-site; USD 90,000 - 130,000; Full time

Job summary

Terumo Aortic is seeking a dedicated quality assurance professional to analyze, investigate, and resolve external customer complaints in line with FDA, ISO, EU MDR, and other regulatory requirements.

You will drive complaint investigations, adverse-event reporting support, trending, and post-market surveillance activities while helping improve complaint processes and team capability across cross-functional groups. Strong knowledge of medical-device regulations is essential.

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, or related field with at least 3 years in medical-device QA or clinical setting.
• At least four years of quality, complaint-investigation and resolution or clinical experience in disposable medical-device industry.
• Clinical experience or in-depth knowledge of interventional products and medical procedures preferred.
• ASQ CQE or CQIA certification desirable.

Responsibilities

• Analyze, evaluate, and investigate external customer complaints per regulatory requirements.
• Drive complaint investigations with cross-functional teams and post-market surveillance.
• Ensure compliance with FDA, EU MDR, and related reporting; support reportability decisions.
• Serve as Post-Market Surveillance SME for assigned product lines.
• Collect follow-up information and coordinate clinical-sample investigations.

Skills

Medical-device regulations

Complaint handling

Medical Device Reporting

Vigilance reporting

Recordkeeping

Analytical thinking

Education

Bachelor’s degree in Engineering, Life Sciences, or related field

ASQ CQE or CQIA certification desirable

Tools

Microsoft Word

PowerPoint

Excel

Minitab

Job description

Terumo Aortic is seeking a dedicated quality assurance professional to analyze, investigate, and resolve external customer complaints in line with FDA, ISO, EU MDR, and other regulatory requirements.

You will drive complaint investigations, adverse-event reporting support, trending, and post-market surveillance activities while helping improve complaint processes and team capability across cross-functional groups. Strong knowledge of medical-device regulations is essential.