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

Overview

Evident Inspection Technologies, a Wabtec company, is a world leader in the manufacture of innovative inspection equipment used in industrial and research applications in the aerospace, power generation, petrochemical, civil infrastructure, automotive and consumer products industries. We offer a wide range of ultrasonic and eddy current flaw detection software and equipment. Our equipment is used, among other things, to inspect welds, detect hidden cracks, voids, porosity, and other internal irregularities in various materials.

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. In addition, this position would provide regulatory support for the ANI / NDT / RVI product lines in the EMEA region.

Tasks

• Maintain customer complaint handling process for ANI / NDT / RVI
• Maintain ISO certificates within the region
• Regulatory review of products labelling 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, quality defects and other issues related to manufacturer product
• Maintain modify and author SOPs related to the ANI / NDT / RVI product lines.
• Actively contribute to the IMS to continually improve processes efficiency and quality
• Participate in Internal Audits
• Assist in coordination of audit responses to customers and other external auditors
• Assist in audit follow up for training compliance findings
• Perform internal compliance audits prepare report and follow up on findings
• Periodic reporting on group activitiesSupport the QA / RA personnel within the APAC / China region

Requirements

• BS or equivalent (technical field desired) Science / Engineering background an asset
• 3+ years of experience dealing directly with national regulatory agencies.
• Experienced in Corrective Action / Root Cause processes.
• Working knowledge of ISO 9001 (ISO 14001 ISO 45001 a plus)
• Familiarity with dealing with regulatory authorities and / or processes in the EMEA.
• Previous work in a medium to large organization dealing with regulated industrial products
• Analytical with a strong ability to determine quantify and solve problems.
• Ability and want to learn and apply knowledge.
• Excellent communication and project leadership skills.
• Highly organized ability to manage multiple projects analyze risk and set priorities
• 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 (Stadtküche)
• Public transport ticket (100% subsidized) or free parking space
• Bike leasing
• Subsidy fitness first gym
• Employee Assistance Program to support your health, mental and emotional well-being
• Comprehensive company pension scheme
• Joint company events and activities

Evident Inspection Technologies Germany GmbH is an equal opportunities employer and we look forward to receiving your application.

Headquartered in Tokyo, Japan, Evident employs around 4,500 people at a total of 57 locations worldwide. Evident Europe, headquartered in Hamburg, Germany, employs approximately 770 people in 16 countries. The product portfolio includes a wide range of microscope systems used in clinical diagnostics, medical and basic research, as well as in various industrial areas. In addition, Evident offers videoscopes, products for non-destructive testing techniques and for X-ray fluorescence analysis.

#J-18808-Ljbffr