Process Quality Engineer
Posted 20 days ago · 0 applicants
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The role in plain words
The Process Quality Engineer manages production deviations, leads root-cause investigations, and coordinates engineering changes to ensure product quality. Day-to-day tasks include writing technical documentation, validating production processes and equipment, and supporting teams across R&D, QC, and subcontractors. The role also focuses on streamlining production lines to improve efficiency and reduce costs.
- 2 - 4 years of experience as an engineer
- 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
Extracted from the job description · kept up to date automatically
Who this suits
This role suits an energetic engineer with a B.Sc. in Mechanical Engineering or a related discipline and 2 to 4 years of experience, ideally in medical devices. It is less ideal for those seeking a remote position or those without a hands-on approach to production line technologies and technical drawings.
Full job description
Original listing · kept for referenceAbout 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
Questions about this role
- This listing did not state a salary. We only show pay when the employer publishes it.
- 2 - 4 years of experience as an engineer, 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