Post‑Market Surveillance Associate — Quality & Compliance

Integer Holdings; Plymouth (MN); On-site; USD 54,000 - 79,000; Full time

Benefits offered by this job

Medical Insurance (Health)

Dental Insurance

Vision Insurance

Disability Insurance

Life Insurance

Adoption benefits

401(k) with company matching

Holidays and PTO

Parental leave after 1 year

Job summary

Integer Holdings is seeking an Associate Post Market Surveillance Engineer to support complaint handling, regulatory reporting, and post market surveillance under guidance from senior staff. You will document complaints, assist in investigations, and help ensure compliance with FDA QSR and related regulations.

This role emphasizes data collection, cross-functional collaboration, and adherence to quality systems. The position offers growth within a quality-focused manufacturing environment.

Qualifications

• Minimum Education and Experience: Associate's or two-year degree and 0-3 years of experience. Candidates who do not meet the education requirement may be considered if they have a minimum of 3 years' relevant experience such as organizing and accurately controlling large amounts of detailed information and product handling.
• Specialized Knowledge: ability to work independently as well as collaboratively with other associates and cross functional teams.
• Specialized Skills: written and oral communications; competent with Microsoft Office and able to stay organized and focused on multiple projects.

Responsibilities

• Support Complaint Handling, Regulatory Reporting and Post Market Surveillance under guidance from experienced associates.
• Capture and document all complaints in the database; send acknowledgements.
• Track customer return products and assist in investigations with cross-functional teams.
• Assist data collection and root-cause investigations to support product quality and patient safety.
• Support timely closure of investigations to comply with FDA requirements and other authorities.
• Collaborate with internal/external customers to gather information for investigations.

Skills

Attention to detail

Written and oral communication

Independence

Cross-functional collaboration

Time management

Education

Associate's or two-year degree

Tools

Microsoft Office

Job description

Integer Holdings is seeking an Associate Post Market Surveillance Engineer to support complaint handling, regulatory reporting, and post market surveillance under guidance from senior staff. You will document complaints, assist in investigations, and help ensure compliance with FDA QSR and related regulations.

This role emphasizes data collection, cross-functional collaboration, and adherence to quality systems. The position offers growth within a quality-focused manufacturing environment.