Post-Market Surveillance Engineer (Associate)

integer; Plymouth (MN); On-site; USD 75,000 - 115,000; Full time

Job summary

Integer is seeking a Post Market Surveillance Engineer to support complaint handling, regulatory reporting and post market surveillance processes under guidance from senior associates. You will help analyze, evaluate and investigate customer complaints to comply with FDA 21 CFR (QSR) requirements and other regulatory bodies.

You will document complaints in the database, assist in investigations with cross-functional teams, participate in audits, and help improve quality systems while ensuring

Qualifications

• Experience with FDA 21 CFR (QSR) requirements.
• Able to document complaints accurately in the complaint handling database.
• Collaborate with cross-functional teams on investigations and communications.

Responsibilities

• Capture and document all complaints in the complaint handling database per internal policies.
• Send complaint acknowledgements to customers.
• Track customer return products.
• Support complaint investigations with cross-functional teams and generate investigation reports.
• Interface with internal and external customers to gather information for investigations.
• Assist in data collection and root cause investigations for product quality and patient safety.
• Support timely closure of investigations to comply with FDA and other regulatory bodies.

Skills

FDA regulations

Regulatory reporting

Data documentation

Job description

Integer is seeking a Post Market Surveillance Engineer to support complaint handling, regulatory reporting and post market surveillance processes under guidance from senior associates. You will help analyze, evaluate and investigate customer complaints to comply with FDA 21 CFR (QSR) requirements and other regulatory bodies.

You will document complaints in the database, assist in investigations with cross-functional teams, participate in audits, and help improve quality systems while ensuring