QA Engineer – Complaints

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 Operations 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:

We are seeking an experienced QA Engineer with a strong background in quality assurance processes within a medical device environment with proficiency in handling complaint investigations management compliant with CFR Part 820 requirements.

• Develop and implement quality system procedures in accordance with CFR Part 820 and other applicable regulations.
• Serve as the primary point of contact for all customer complaints related to our medical device products, ensuring a prompt and customer-focused response.
• Maintain a thorough and compliant complaint handling system, aligning with CFR Part 820 requirements, and ensure that all complaints are documented, investigated, and resolved according to established SOPs and regulatory guidelines.
• Lead the complaints investigation process, including gathering data from customers, coordinating with cross-functional teams, and conducting root cause analyses to understand the underlying issues.
• Develop and implement corrective and preventive actions (CAPA) stemming from complaint investigations, and monitor the effectiveness of these actions.
• Prepare and present complaint trends for management review meetings, highlighting potential risks and areas for quality improvements.
• Ensure the integration of the complaint handling process with other quality system elements, such as risk management, CAPA, and audits.
• Maintain an up-to-date knowledge base on the latest complaint handling regulations, industry best practices, and continuous improvement processes.
• Perform internal audits and support external audits to ensure compliance with quality management systems.
• Support additional QA activities as they evolve.

Job Requirements:

• Education:BSc in Engineering or practical engineering – life sciences – advantage
• Certified Quality Engineer (CQE) – advantage
• Job skills: 3-5 years experience in quality assurance, preferably with QMS management and complaints, in a medical device or pharma manufacturing company according to GMP and regulatory requirements (FDA CFR PART 820, ISO 13485, 9001) - Must
• Proven experience with ISO14001 EMS systems – Advantage
• Proven experience in Audits (CE, FDA)- 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