Jobs in Germany: Quality Assurance and Regulatory Affairs Expert at Amaris

OPPORTUNITY DETAILS

Total reward

0 $

Nonprofit organization

Amaris

Area

Central and Eastern Europe

Host Country

Germany

Deadline

10 Dec 2020

Study level

Undergraduate

Opportunity type

Jobs

Specialities

Engineering , Science

Opportunity funding

Full funding

Eligible Countries

Algeria , Comoros , Egypt , Jordan , Lebanon , Mauritania , Oman , Qatar , Somalia , Syria , United Arab Emirates , Bahrain , Djibouti , Iraq , Kuwait , Libya , Morocco , Palestine , Saudi Arabia , Sudan , Tunisia , Yemen

Eligible Region

All Regions

Amaris is offering a job opportunity as a Quality Assurance and Regulatory Affairs Expert to join the team in Germany for 2020.

Responsibilities:

Implement all Regulatory and Quality Assurance activities according to procedures and regulatory requirements.
Provide oversight to ensure that the company is 100% compliant with international regulatory requirements.
Review product design for compliance with engineering principles, company standards, and customer contract requirements, and related specifications.
Monitor and continuously improve the Quality system by evaluating supporting documentation to ensure compliance to Industry standards, and other applicable regulations.
Work with other team members to develop, document, and validate functional requirements and user requirements for electronic quality processes.
Attend relevant briefings, presenting the outcome and providing reviews and assessments, orally and in writing, in a timely manner.
Assist in the design, development, and implementation of an electronic document management system that will manage (i.e., draft, edit, and approve) documentation, as well as serve as a repository for approved documents with search and retrieve capabilities.
Perform product testing and failure analysis, data logging of quality data and trend results.
Perform other duties as assigned.

Requirements:

Bachelor’s Degree in a scientific/engineering field; Master of Science preferred.
Minimum 5 years of experience in the medical device industry.
Minimum of 3+ years’ experience in Regulatory Affairs, Engineering, Quality Assurance.
Proficiency in English (other languages would be a plus).

Benefits:

A modern, dynamic, future-oriented company.
Continuous development and training opportunities.
Comprehensive training on application from functional and technical aspect and about data structures
Appealing social benefits (including meal vouchers, pension insurance, ...).
Interesting and challenging tasks.
Flexible working hours and home office options.
Independent and varied work.
Working in an international and multicultural environment.
International technical communities.
Regular team events.
Long-term perspective.

About Amaris:

It is an independent, international Technologies and Management Consulting Group. Created in 2007, Amaris is already established in over 50 countries and supports more than 750 clients worldwide throughout their project's lifecycle. Their expertise covers five areas of innovation: Business and Management, Information Technologies, Engineering and High Technologies, Telecommunications, and Biotech and Pharma. With more than 65 offices across the world, the Group offers proximity support to its clients in all their locations and many opportunities of international careers for employees. In 2018, Amaris aims to reach a turnover of 260 million euros, 5,000 employees and to develop its workforces with the anticipation of a further 2,000 new job openings.

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