Process Quality Engineer at PI-Cardia

Rehovot, Center District, Israel -

Full Time

Start Date

Immediate

Expiry Date

21 Mar, 26

Salary

0.0

Posted On

21 Dec, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Process Quality Engineering, Root-Cause Investigation, Technical Documentation, Production Support, Continuous Improvement, Production Technologies, QC Instructions, High-Level English, Drawing Interpretation, Hands-On Approach, Multitasking, Responsibility, Self-Learning, Interpersonal Communication, Diligence, Energy

Industry

Medical Equipment Manufacturing

Description

Pi-Cardia, a dynamic medical device startup specializing in cardiovascular innovations, is looking for a dedicated and detail-oriented Process Quality Engineer to join our team. The Quality Engineer is responsible for managing production deviations, leading root-cause investigations, and coordinating engineering changes to ensure product quality and compliance. The role includes developing technical documentation, validating processes and equipment, and providing ongoing support across R&D, production, QC, and subcontractors. Additionally, the position drives continuous improvement initiatives to streamline production lines and enhance operational efficiency. Responsibilities: The Quality Engineer will be responsible for handling deviations in production and managing the revision processes Opening exceptions for malfunctions in production In-house, in the QC, or at sub-contractors Investigating abnormalities in production and locating the route cause Opening and managing engineering changes Writing product/production files Writing production/testing instructions and defining technical specifications Validation of production processes and equipment Ongoing product support while communicating with R&D, logistics, marketing, production, and subcontractors Streamlining the production lines (by new technologies, reducing costs, reducing times, etc.) Requirements 2 - 4 years of experience as an engineer preferably in medical devices Knowledge of production technologies and experience working with production lines Experience in writing production and QC instructions and specifications English at a very high level with an emphasis on writing Good ability to read and understand drawings and specifications HANDS-ON approach Ability to lead processes Multitasks ability Takes responsibility High self-learning capability High interpersonal communication Energetic, diligent Education - Engineering, biotechnology, materials, biomedicine, preference for machines

Responsibilities

The Quality Engineer is responsible for managing production deviations and leading root-cause investigations to ensure product quality. This role also involves developing technical documentation and providing ongoing support across various departments.