Quality Engineer
Posted Jun 28 · 128 applicants
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The role in plain words
This Design QA Engineer acts as the quality focal point for pharmaceutical device projects from initial design through to production transfer. Day-to-day responsibilities include controlling project documentation, investigating part and process deviations, handling non-conformities, and representing quality requirements directly to customers.
- At least 2 years of experience working according to GMP and regulatory requirements (FDA QSR part 820, ISO 13485)
- Good knowledge of MS-Office tools (Excel, Word)
- Acquaintance with E-Document management systems
- High level written and spoken English
- Practical Engineer/ B.Sc. in Quality/ Biomedical/ Biotechnology or similar
- CMQ / CQE or similar certification
Extracted from the job description · kept up to date automatically
Who this suits
This role suits individuals with at least 2 years of experience working under GMP and medical device regulatory standards like ISO 13485 and FDA QSR part 820. It is less ideal for candidates seeking fully remote work or those without experience in regulated quality management systems.
Full job description
Original listing · kept for referenceAbout 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.
Questions about this role
- This listing did not state a salary. We only show pay when the employer publishes it.
- Hybrid
- At least 2 years of experience working according to GMP and regulatory requirements (FDA QSR part 820, ISO 13485), Good knowledge of MS-Office tools (Excel, Word), Acquaintance with E-Document management systems, High level written and spoken English