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:
- Sc in Engineering or practical engineer – life sciences – advantage
- Certified Quality Engineer (CQE) – advantage
- Job skills:
- 3-5 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) - 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
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