# Process Quality Engineer

[Pi Cardia](https://gurify.com/jobs?q=Pi%20Cardia) · Rehovot, Israel · Posted 2 weeks ago

[Apply on the original posting → (opens in a new tab)](https://www.comeet.com/jobs/pi-cardia/A5.00B/process-quality-engineer/6C.D64)

## Job description

### About Pi-Cardia

Pi-Cardia is a growth-stage medical device company focused on developing innovative solutions for structural heart disease. Founded in Israel, with expanding operations in the United States, Pi-Cardia combines clinical excellence, technological innovation, and entrepreneurial agility. Our team works closely with leading physicians and global partners to bring meaningful, life-improving therapies to patients worldwide. We are building a high-performance organization that balances rapid growth with operational discipline, regulatory excellence, and a strong people-first culture.

### Position Overview

﻿The Process 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

- B.Sc. in Mechanical Engineering or another engineering discipline, with strong experience in mechanical product manufacturing

**Live in Pi Cardia’s hiring system.** Read from the company's own applicant tracking system, not reposted from a job board — so it's a real, open requisition rather than an ad that outlived the role.

We remove it as soon as it disappears at source.

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