Design QA 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