Post-Market Quality Technician, Medical Devices

Insulet Corporation; Waalwijk; On-site; EUR 42,000 - 62,000; Full time

Job summary

Insulet Corporation is seeking a Post Market Quality Associate to support the Quality Department with post market investigations of FDA‑approved medical devices. The role requires strong organizational skills, attention to detail, and the ability to work in cross‑functional teams to meet departmental and company goals.

Minimum requirements include an MBO or Associate’s degree in engineering or a scientific discipline, with preferred experience in a regulated medical device environment and in QA

Qualifications

• Minimum requirements: MBO or Associates Degree in an engineering, or scientific discipline.
• Preferred 2 years in a Quality related function with QSR and/or ISO 13485.

Responsibilities

• Perform moderately complex tasks to ensure compliance with quality standards.
• Determine if materials meet requirements for investigation.
• Execute initial inspection for received material.
• Extract data from returned materials.
• Collaborate with QA engineers to implement and maintain inspection/testing procedures.
• Generate, review and maintain Quality records (training, internal audits, NCR, CAPA).
• Review Lot Acceptance records and DHRs.
• Log quality data and trend results.
• Ensure accurate quality data entry and productivity.
• Assist during FDA and ISO 13485 inspections.
• Perform investigation triage leading to trend analysis and CAPA.
• Evaluate process/engineering controls to improve safety and efficiency.
• Perform other duties as assigned.

Skills

Electrical background

Mechanical background

Regulated industry experience

Quality function experience

Excel & data analysis

Technical writing

Education

MBO or Associates Degree in engineering or scientific discipline

Job description

Insulet Corporation is seeking a Post Market Quality Associate to support the Quality Department with post market investigations of FDA‑approved medical devices. The role requires strong organizational skills, attention to detail, and the ability to work in cross‑functional teams to meet departmental and company goals.

Minimum requirements include an MBO or Associate’s degree in engineering or a scientific discipline, with preferred experience in a regulated medical device environment and in QA