Regulatory Affairs Sr. Consultant
PQE Group is a Contract Quality Organisation and a Complete Quality Solution provider for GCP, GLP, GMP & GDP areas in the Life Science Industry. Since 1998, we have successfully completed more than 7,000 projects worldwide and now serve our Clients from offices in Italy, Spain, Switzerland, Germany, LATAM, USA, the Middle East, China, India and Japan. As an international group we have experience working in more than 25 languages and have an excellent history of supporting small, medium and large size companies exceeding compliance standards from the FDA / EMA / WHO / TGA / SFDA / ANVISA / INVIMA / GILS and other local authorities. PQE Group offers turn key quality solutions and focuses on offering exceptional cost effectiveness, whilst maintaining highest quality standards for our Clients.
Due to constant growth, PQE is looking for a Software Quality Engineer available to join our team in Israel.
- Verification and validation of software system requirements
- Perform and document risk analysis
- Running tests on software or applications and analyze defects in order to improve products
- Ensure that project and documents related to SW development process are managed according to procedure
- Responsible for software quality challenges and software quality improvement opportunities
- New product development
Responsabilities include, but are not limited to, the following:
- Technical Degree (Engineering, Chemistry, Informatics, Physics, Mathematics)
- 2 - 4 years of experience in Life science
- Knowledge of ISO 13485 and Quality Systems
- Availability to travel domestically and abroad (at least 50%)
- Integrity, strong analytical skills and attention to details
- Excellent use of major productivity SW (e.g.: MS Office)
- Good communication and interpersonal skills
- Client-oriented, dedicated, flexible, able to manage timelines and prioritize your work
- Fluent English (at least B2/C1 Level)
- Any knowledge of a second language would be considered as plus
Our collaborators are engaged, developed, challenged and well-rewarded for performance. We recognize the importance of leadership at all levels of our organization in order to succeed in a challenging business environment, and we are committed to providing practical processes and programs to identify, develop and inspire all our current and future leaders.