QA Engineer – Complaints Associate

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 QA Complaints Associate to join our team in Israel.

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

Job Description:

We are looking for a junior QA Engineer with strong computer skills and the ability to self-learn, to manage complaint investigations in compliance with CFR Part 820.

Serve as the point of contact for all customer complaints related to our medical device products, ensuring prompt and customer-focused responses.
Maintain a robust and compliant complaint handling system aligned with CFR Part 820. Ensure that all complaints are documented, investigated, and resolved in accordance with SOPs and regulatory requirements.
Participate in the complaint investigation process, including data collection from customers, coordination with cross-functional teams, and root cause analysis.
Monitor the implementation, completion, and effectiveness of corrective actions resulting from complaint investigations.
Stay up to date with relevant regulations, industry best practices, and continuous improvement initiatives.
Support additional QA activities as needed.

Job Requirements:

Education:
Sc. in Engineering or practical engineer - advantage
Certified Quality Engineer (CQE) – advantage
Job skills:
0-2 years’ experience in quality assurance, preferably with QMS management /projects, in a medical device or pharma manufacturing company according to GMP and regulatory requirements (FDA CFR PART 820, ISO 13485, 9001) – Advantage

Computer skills: Full control of all MS-Office applications

Language skills: Fluent English - writing and verbal
Personal Skills: Very high interpersonal capabilities, assertive and Collaborative ability to work in Multidisciplinary work opposite various stakeholders internally and externally