Evident Microscopy
QA/RA Engineer (m/f/d) – EMEA
Evident Microscopy
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.
Responsibilities
Assist in maintaining the Global Integrated Management System (IMS) with a specific emphasis on EMEA.
Provide regulatory support for the ANI/NDT/RVI product lines in the EMEA region.
Maintain customer complaint handling process for ANI/NDT/RVI.
Maintain ISO certificates within the region.
Regulatory review of product labeling and literature pre‑release.
Maintain EMEA product registrations for NDT/ANI/RVI products.
Maintain EMEA X‑Ray registrations for ANI products.
Liaise with manufacturers on EMEA product registration matters, quality defects and other issues related to manufacturer product.
Modify and author SOPs related to the ANI/NDT/RVI product lines.
Actively contribute to the IMS to continually improve process 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 reports and follow up on findings.
Periodic reporting on group activities and support 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 willingness to learn and apply knowledge.
Excellent communication and project leadership skills.
Highly organized; ability to manage multiple projects, analyze risk and set priorities.
Ability 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 near 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.
#J-18808-Ljbffr
Evident Microscopy
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.
Responsibilities
Assist in maintaining the Global Integrated Management System (IMS) with a specific emphasis on EMEA.
Provide regulatory support for the ANI/NDT/RVI product lines in the EMEA region.
Maintain customer complaint handling process for ANI/NDT/RVI.
Maintain ISO certificates within the region.
Regulatory review of product labeling and literature pre‑release.
Maintain EMEA product registrations for NDT/ANI/RVI products.
Maintain EMEA X‑Ray registrations for ANI products.
Liaise with manufacturers on EMEA product registration matters, quality defects and other issues related to manufacturer product.
Modify and author SOPs related to the ANI/NDT/RVI product lines.
Actively contribute to the IMS to continually improve process 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 reports and follow up on findings.
Periodic reporting on group activities and support 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 willingness to learn and apply knowledge.
Excellent communication and project leadership skills.
Highly organized; ability to manage multiple projects, analyze risk and set priorities.
Ability 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 near 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.
#J-18808-Ljbffr