Quality Assurance Engineer

Quality Assurance Engineer

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Your unique talents will help patients on their journey to wellness.

We are searching for the best talent for Quality Assurance Engineer position, to join our Quality Assurance team in Tel Hashomer, Israel. If you're passionate about product quality, continuous improvement, and want to make a meaningful impact in a dynamic environment, we encourage you to apply.

Job Summary:

The Quality Assurance Engineer is responsible for supporting quality activities across the manufacturing site, with a focus on deviation investigations, risk assessments, and product disposition. The role ensures that quality and regulatory requirements are met by leading root cause analyses, supporting change control processes, and representing QA in cross-functional projects. This position plays a key role in maintaining product quality and driving continuous improvement through effective implementation of corrective and preventive actions.

Duties & Responsibilities:

• Lead and support quality investigations (deviations), ensuring thorough root cause analysis and implementation of appropriate corrective and preventive actions (CAPA).
• Author and manage risk assessments related to deviations and changes, ensuring alignment with product quality and patient safety.
• Prepare and approve product disposition justifications related to deviations, ensuring adequate mitigations are in place.
• Serve as the QA representative in cross-functional project teams within manufacturing, ensuring quality requirements are met throughout project execution.
• Review and support change controls, including leading functional impact assessments and risk analyses, to ensure continued product quality and compliance.
• Maintain compliance with GMP and other applicable regulatory standards.
• Perform other assigned duties as needed.

Qualifications:

Experience and Education:

• Bachelor/master's degree in science/technology/engineering/Industrial engineering or relevant field.
• 2-3 years of related experience preferred

Required Knowledge, Skills, Abilities, Certifications/Licenses:

• Strong understanding of GMP principles and regulatory requirements.
• Experience in quality investigations, risk management, and deviation handling within a pharmaceutical or biotech environment.
• Ability to collaborate cross-functionally and communicate effectively.
• Detail-oriented with strong documentation and analytical skills.
• Willingness to perform duties in accordance with policies and comply with industry regulations.

Additional Position Requirements:

• Ability to write clearly and concisely in English and Hebrew
• Strong interpersonal and communication skills, with ability to work effectively in cross-functional teams
• Attention to detail and ability to manage multiple priorities in a dynamic environment
• Familiarity with regulatory guidelines (e.g., EMA, FDA, ICH) – an advantage

Physical Working Conditions/Requirements:

Availability for full-time on-site / hybrid work at the manufacturing site in Tel-Hashomer.