Complaints Handler

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