Quality Assurance Manager

Come work with us @OliveDx.

Our Quality Assurance (QA) Manager will report directly to the EVP of R&D and Engineering, and will oversee all aspects related to the company QMS and quality aspects of Production and R&D.

Job Description:

·    Lead together with the team, the implementation of an eQMS SW.

·    Lead, inspect, and coordinate external audits for ISO 13485.

·    Draft, review, and approve company documents, specifications, drawings, and procedures.

·    Ensure traceability through meticulous document tracking.

·    Initiate improvement mechanisms, including document control, change control, deviation handling, and preventive/corrective actions (ECO, NCR, MRB, CAPA).

·    Manage the company's training and certification activities.

·    Prepare and present management reviews.

·    Schedule internal audits and conduct supplier audits and evaluations.

·    Address and resolve customer and supplier complaints.

·    Monitor and manage technical files.

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Job Requirements:

Managing and Responsible for the implementation of all QMS activities·    Academic degree in life sciences, medicine, pharmacy, engineering, or a related discipline.

·    Certification or other evidence of formal qualification in quality management QMS (ISO 13485).

·    Former similar position in a medical device company of at least 3 years.

·    Background in managing the transfer from R&D to production and mature products- Advantage.

·    Excellent reading, writing, and communication skills in English and Hebrew.

·    Strong reporting, teamwork, and time management skills.

·    Ability to learn quickly, analyze problems, work independently, and effectively organize and execute multiple work tasks.

·    Presence in Company's offices in Modi’in (flexibility in working hours)

·    Part time Position of 75%

Send CV to:     [email protected]

In the title, please indicate: For the position of Quality Manager