Quality Assurance Associate

Insulet Corporation; Waalwijk; On-site; EUR 35,000 - 45,000; Full time

Job summary

Join a leading company as a Quality Assurance Associate responsible for ensuring compliance with quality standards in a dynamic environment. You will perform inspections, manage materials, and support quality initiatives in the medical device industry. This entry-level role offers a chance to grow within a dedicated team focused on improving diabetes management through innovative solutions.

Qualifications

• Minimum requirements include a high school diploma in engineering or scientific discipline.

Responsibilities

• Perform complex tasks to ensure compliance with quality standards.
• Conduct lot qualification testing.
• Inspect nonstock materials and manage disposables.

Skills

Communication

Record Keeping

Education

High school diploma in engineering or scientific discipline

Tools

MS Office

Job description

Join to apply for the Quality Assurance Associate role at Insulet Corporation.

Get AI-powered advice on this job and more exclusive features.

Position Overview

The Quality Assurance Associate will be responsible for controlling inspection of incoming materials to support Insulet European lab and performing rework activities. The role requires dealing with changing priorities and inspecting incoming materials for nonstock orders, QC lots, and receiving complaints. Rework activities will be performed for Lot qualification in the lab.

Responsibilities

• Perform complex tasks to ensure compliance with quality standards.
• Conduct lot qualification testing.
• Inspect nonstock materials, transfer them to designated locations, monitor disposable stock, and install ad hoc tooling as needed.
• Perform rework activities following instructions.
• Handle office-related activities such as issuing orders, contacting suppliers, and managing disposables.
• Arrange shipments from the facility.
• Register RMA complaints and maintain quality records.
• Assist during FDA and ISO 13485 inspections.
• Support lean management initiatives onsite.
• Perform other duties as assigned.

Education and Experience

Minimum Requirements: High school diploma in engineering or scientific discipline.

Preferred Skills and Competencies

• Proficiency in MS Office (Excel preferred).
• Electrical and mechanical background preferred.
• Knowledge of Lean methodologies preferred.
• Experience in regulated industries (medical device) or lab environments preferred.
• Experience with QMS and ISO 13485 preferred.
• Strong communication skills.
• Excellent record-keeping skills.

Physical Requirements

• Sitting and standing 50% each.
• Frequent lifting and handling up to 25kg.
• Ability to operate basic hand tools.

Insulet Corporation, headquartered in Massachusetts, is dedicated to simplifying life for people with diabetes through its Omnipod product platform, including the Omnipod 5 Automated Insulin Delivery System. For more information, visit insulet.com and omnipod.com.

Additional Details

• Seniority level: Entry level
• Employment type: Full-time
• Job function: Quality Assurance
• Industry: Medical Equipment Manufacturing