Design QA Engineer

About us

LTS is a leading pharmaceutical technology company that develops and manufactures innovative drug delivery systems for the pharmaceutical industry.

LTS´ commercial offering encompasses more than 20 marketed products.

LTS operates today from 5 sites: Netanya (Israel), Adrenarche (Germany), West Caldwell (NJ, USA), St. Paul (MN, USA), and Shanghai (China).

About the role 

We are looking for an excellent Design QA Engineer to join our team in Israel.

The position is hybrid - 4 days a week from the office, and 1 day from home.

Responsibilities:

• Be the QA focal point design and development of projects throughout the product design process until transfer to production
  • Provide quick solutions to inquires and problems arising during the process
• Control all aspects of project documentation
• Interface with relative personnel to resolve document problems/issues within the design process
• Be a customer facing team member and represent the organization and QA needs to the customer
• Assist in cases of non-conformities (NC) of products, parts and processes
• Supporting production readiness activities and validations
• Perform investigations and collect data on deviations of parts, materials or processes throughout the organization, while working with other departments

Direct manager: QA Manager

Job Requirements:

• Education:
  • Practical Engineer/ B.Sc. in Quality/ Biomedical/ Biotechnology or similar - an advantage
  • CMQ / CQE or similar - an advantage

• Job skills:
  • At least 2 year of experience in working according to GMP and regulatory requirements (FDA QSR part 820, ISO 13485) – mandatory
  • Previous experience in QA design work – significant advantage
  • Experience with QMS and production - significant advantage
  • Experience in the field of Medical Devices - an advantage
• Computer skills:
  • Good knowledge of MS-Office tools (Excel, Word),
  • Acquaintance with E-Document management systems
• Language skills:
  
  • English - high level (written and spoken)
• Personality:

At LTS, we value collaboration, innovation, and accountability.

We're looking for individuals who can:

• Teamwork: Collaborate effectively, embracing diverse perspectives.
• Customer Focus: Exceed internal and external customer needs.
• Innovation: Create new opportunities with enthusiasm.
• Accountability: Take ownership of challenges, uphold standards.
• Leadership: Motivate and develop talents, achieving goals.