QARA Engineer (mfd) EMEA

EVIDENT Europe GmbH; Hamburg; Hybrid; EUR 50.000 - 70.000; Vollzeit

Zusammenfassung

A leading inspection technology company in Hamburg is seeking a QA / RA Engineer to assist in regulatory support and maintain the Global Integrated Management System. The ideal candidate should have a BS in a technical field, 3 years of experience with regulatory agencies, and knowledge of ISO standards. Benefits include flexible working hours, significant vacation days, and a modern office environment.

Leistungen

Flexible working hours

30 days of holiday

135 salaries a year

Modern office

Subsidized meals

Public transport ticket or free parking

Bike leasing

Gym subsidy

Employee Assistance Program

Company pension scheme

Company events

Qualifikationen

• 3 years of experience dealing with national regulatory agencies.
• Experienced in Corrective Action / Root Cause processes.
• Working knowledge of ISO 9001 and familiarity with regulatory processes in EMEA.

Aufgaben

• Maintain customer complaint handling process for ANI / NDT / RVI.
• Maintain ISO certificates and product registrations.
• Participate in internal audits and coordinate audit responses.

Kenntnisse

Corporate Communications

Apache Commons

Community Support

Jira

Java

Ausbildung

BS or equivalent in a technical field

Jobbeschreibung

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) 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
• 135 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

Key Skills

• Corporate Communications
• Apache Commons
• Community Support
• Jira
• Java

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