Design QA Engineer at LTS DT

Netanya, Center District, Israel -

Full Time

Start Date

Immediate

Expiry Date

21 Mar, 26

Salary

0.0

Posted On

21 Dec, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

GMP, Regulatory Requirements, QA Design Work, QMS, Medical Devices, Problem Solving, Detail Oriented, Analytical Skills, Teamwork, Documentation Control, Customer Facing, Production Readiness, Investigations, Data Collection, Multitasking, Self-Starter

Industry

Pharmaceutical Manufacturing

Description

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

Responsibilities

The Design QA Engineer will be the QA focal point during the design and development of projects, ensuring quality throughout the product design process until transfer to production. They will also assist in resolving document issues and support production readiness activities.