QA Supplier and Operations Engineer

• 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).
• About the role
• We are looking for an excellent QA Supplier and Operations Engineer to join our team in Israel.
• The position is permanent, full time, hybrid.

Responsibilities

• Support supplier qualification, monitoring, documentation review, quality agreements, and supplier change notifications.
• Assist with supplier-related non-conformances and SCARs, including follow-up of investigations, corrective actions, closure, and effectiveness evidence.
• Support supplier audit activities, including preparation, documentation of findings, supplier response follow-up, and action tracking.
• Assist with component and supplier qualification activities, including documentation collection, quality review, and cross-functional coordination.
• Provide QA support for GMP manufacturing activities, including production quality events, deviations, NCMRs, and quality documentation review.
• Support cleanroom quality activities, including environmental monitoring follow-up, contamination control, excursions, microbial sampling, and related documentation.
• Review SOPs, protocols, reports, GMP records, ECOs, supplier documents, deviations, and validation-related documents under guidance.
• Assist with ECOs, supplier changes, and process change assessments, including documentation review and implementation follow-up.
• Collect and summarize supplier and QA operational quality data, including supplier performance, SCARs, audit findings, NCMRs, cleanroom excursions, and EM trends.
• Support continuous improvement activities related to supplier management, investigations, documentation practices, and cleanroom/production quality processes.
• Support internal, customer, regulatory, and supplier audits by preparing objective evidence and tracking audit-related actions.
• Perform activities in accordance with GMP, ISO 13485, applicable regulatory requirements, LTS procedures, quality agreements, and customer requirements.

Direct Manager: QA suppliers and NC Team Leader

Job Requirements

• Education:
• BSc in Life Sciences, Biotechnology, Biomedical Engineering, Quality Engineering, Industrial Engineering, or similar – must.
• CMQ / CQE / CQA / ASQ certification, Six Sigma certification, or relevant quality/auditor certification – advantage.
• Master’s degree in a relevant field – advantage.
• Job skills:
• 0-2 years of relevant experience in supplier quality, QA operations, quality engineering, production quality support, or GMP manufacturing support in a medical device, pharmaceutical, or biotech environment – must.
• Previous experience in the medical device or pharmaceutical industry – must.
• Experience with supplier qualification, supplier monitoring, supplier audits, quality agreements, supplier change notifications, supplier-related non-conformances, SCARs, and supplier CAPA effectiveness assessment – strong advantage.
• Experience with NC/NCMR handling, deviation investigations, root cause analysis, CAPA follow-up, and effectiveness verification – strong advantage.
• Good understanding of GMP and quality system principles. Knowledge of ISO 13485, ISO 9001, FDA QMSR/21 CFR Part 820, and applicable international standards – advantage.
• Experience with quality documentation review, ECO support, GMP records, SOPs, protocols, reports, validation-related documentation, supplier documentation, and audit evidence preparation.
• Ability to conduct effective root cause investigations and critically assess corrective action strategies, implementation evidence, and effectiveness as applied to both internal quality events and supplier-related SCARs.
• Strong analytical ability, attention to detail, audit-readiness mindset, and ability to prioritize topics with potential quality, compliance, production, or customer impact.
• Ability to work independently while collaborating effectively with cross-functional interfaces and external suppliers.
• Computer skills:
• Full proficiency with Microsoft Office applications, including Excel, Word, PowerPoint, Outlook, and Microsoft Project.
• Experience with SAP, QMS/eQMS systems, electronic documentation systems, or supplier management systems – advantage.
• Language skills:
• High-level English writing and verbal communication skills – must.
• Fluent Hebrew – advantage.
• Personality:

At LTS, we value collaboration, innovation, and accountability.

We're looking for individuals who can

• Teamwork: Collaborate effectively, embracing diverse perspectives.
• Customer Focus: Exceed internal and external customer needs.
• Innovation: Create new opportunities with enthusiasm.
• Accountability: Take ownership of challenges, uphold standards.
• Leadership: Motivate and develop talents, achieving goals.