עדיין מחפשים עבודה במנועי חיפוש? הגיע הזמן להשתדרג!
במקום לעבור לבד על אלפי מודעות, Jobify מנתחת את קורות החיים שלך ומציגה לך רק משרות שבאמת מתאימות לך.
מעל 80,000 משרות • 4,000 חדשות ביום
חינם. בלי פרסומות. בלי אותיות קטנות.
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 Engineer – Complaints 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 engineer – 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
במקום לעבור לבד על אלפי מודעות, Jobify מנתחת את קורות החיים שלך ומציגה לך רק משרות שבאמת מתאימות לך.
מעל 80,000 משרות • 4,000 חדשות ביום
חינם. בלי פרסומות. בלי אותיות קטנות.
משרות נוספות מומלצות עבורך
-
מהנדס.ת איכות ואמינות
-
רמת השרון
Elbit Systems
-
-
QA Engineer
-
מגדל העמק
טאואר סמיקונדקטור
-
-
דרוש /ה מהנדס /ת איכות חברה מאזור קיסריה.
-
חיפה
QHR
-
-
מהנדס.ת איכות
-
רמת השרון
אלביט מערכות
-
-
חברה טכנולוגית מובילה מגייסת מהנדס /ת איכות,קליטה ישירה
-
קיסריה
או.אר.אס- סניף חדרה
-
-
דרוש.ה מהנדס.ת איכות בתכנית
-
כרמיאל
Experis Elbit
-