QMS 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 QMS Engineer to join our team in Israel.

The position is hybrid - 4 days a week from the office, and 1 day from home.

Responsibilities:

Primary responsibilities

• Training management: organization, support and documentation of training performance in the company, monitor and track progress and status through the training process, initiate improvement in training process, follow up and ensuring compliance with company policies.

Other responsibilities

• Planning and management of internal and external audits: selection of auditing personnel, planning, scheduling of audits, reviewing audit content, follow-up on the timeliness and completion of action items/corrective action plans.
• Assessment of quality gaps, initiation of improvement in quality process, investigation methodology, creation of new procedures as applicable.
• Support QMS processes as needed: change control, quality plan, NCc / CAPAs, CSV/tooling validation, Costumer complaints,

Direct Manager: QMS Team Leader

Job Requirements:

• Education: BSc in Biomedical/ Engineering/ Life Science or equivalent
• Job skills:
  • 1-3 years of experience in pharma or medical device company
  • Experience in quality assurance, preferably with QMS management/projects - advantage
  • Knowledge of quality management principles, standards, and regulations (FDA CFR 820, ISO 13485, 9001) - advantage
• Computer skills: Proficiency in Microsoft Office programs
• Language skills: Good English, both written and verbal
• 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.