Quality Technician
On-siteWaalwijk, North Brabant, The Netherlands
Job Summary
Perform moderately complex tasks to ensure compliance with quality standards and determine if materials meet requirements for investigation. Execute initial inspections for received materials, extract data from returned items, and generate, review, and maintain quality records supporting the Quality System. Work with quality assurance engineers to implement testing procedures, review Lot Acceptance records, and perform investigation triage leading to trend analysis. Assist in gathering information during FDA and ISO 13485 inspections and evaluate process controls to improve safety and efficiency. This role supports Insulet's Omnipod product platform, which simplifies life for people with diabetes through innovative insulin management systems.
Required Qualifications
- MBO or Associates Degree in an engineering, or scientific discipline
- Must be able to sit 70% of the time
- Must be able to stand 30% of the time
- Must be able to lift less than 5kg frequently
- Must be able to handle (push/pull) up to 23kg occasionally (less than 10% of time)
- Must be able to operate basic hand tools
Desired Qualifications
- Electrical and mechanical background preferred
- Prior experience working in a regulated industry (medical device) and/or experience working in a bio-hazard/lab environment preferred
- Preferred 2 years in a Quality related function working with QSR and/or ISO 13485
- Computer proficiency in MS office (specifically Excel); experience creating and analyzing charts and Pareto charts a plus
- Excellent technical writing skills
- Ability to organize and complete tasks with minimal supervision
- Excels at generating and maintaining organized accurate records
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