Medical Device QA engineer/lead

Company Description

Initia Ltd. is a global leader in innovating and bringing to market unique shockwave therapy systems. The company introduces systems in various fields including Urology, Men's Health, Women's Health, Nephrology, and Chronic Wound care. Although a mid sized company, Initia has active commerciala and clinical activity in most major markets worldwide

Role Description

This is a full-time role for a Medical Device QA/RA Manager at Initia Ltd. in Petah Tikva. The role involves classic QA responsibilities such as ISO 13485 and 14971, as well as product documentation control responsibilities and providing support to RA efforts worldwide. The position has responsibility for coordinating all of the company's QA programs while receiving support from external consultants.

Qualifications

• Several years experience in a QA manager or QA/RA engineer position at a medical device company
• Experience in a product engineering position - advantage
• High level English
• A personality that supports working with international counterparts
• Specific QA or engineering experience related to the China market - advantage
• Bachelor's degree in Biomedical Engineering, or other engineering fields