QA/RA Engineer (m/f/d) - EMEA - Remote

Overview

The QA/RA Engineer (m/f/d) is responsible for assisting in maintenance of the Global Integrated Management System (IMS) with specific emphasis on EMEA (Europe and Middle East and Africa) IMS. This position provides regulatory support for the ANI/NDT/RVI product lines in the EMEA region.

In Short

• Maintain customer complaint handling process for ANI/NDT/RVI.
• Maintain ISO certificates within the region.
• Regulatory review of products labeling and literature pre-release.
• Maintenance of EMEA product registrations for NDT/ANI/RVI products.
• Maintenance of EMEA X-Ray registrations for ANI products.
• Liaise with Manufacturer on EMEA product registration matters.
• Maintain, modify and author SOPs related to the ANI/NDT/RVI product lines.
• Actively contribute to the IMS to improve process efficiency and quality.
• Participate in Internal Audits.
• Assist in coordination of audit responses to customers and external auditors.

Requirements

• BS or equivalent (technical field desired) Science/Engineering background.
• 3+ years of experience with national regulatory agencies.
• Experienced in Corrective Action/Root Cause processes.
• Working knowledge of ISO 9001.
• Familiarity with regulatory authorities in the EMEA.
• Previous work in a medium to large organization with regulated industrial products.
• Analytical with problem-solving skills.
• Excellent communication and project leadership skills.
• Highly organized with ability to manage multiple projects.
• Able to communicate in English, verbally and written.

Benefits

• Flexible working hours, 50% remote work possible.
• 30 days of holiday per year.
• 13.5 salaries a year.
• Modern office and inspiring working environment.
• Subsidized meals in the neighborhood of our office.
• Public transport ticket or free parking space.
• Bike leasing.
• Subsidy for fitness gym.
• Employee Assistance Program for health and well-being.
• Comprehensive company pension scheme.
• Joint company events and activities.