Quality Assurance Engineer

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.

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.

Job Description:

• 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: Director of Quality

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 – mandatory
• 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:
• Problem solving attitude and mediator
• Detail-oriented, dependable and trustworthy
• Ability to evaluate, prioritize, organize, multitask and problem solving
• Ability to work in a fast-paced and deadline-driven environment
• Ability to work in a team as well as independently
• Good analytical skills Self-starter with drive, focus, and initiative