Leadership of Operations Quality, administration, and communication of Quality Assurance (QA) activities, Supplier Quality and Document Control to establish and ensure compliance with relevant regulatory requirements for medical devices. This position reports to Head of QA

Release of devices for human trials, sale and distribution and has the authority to hold products or processes or resume production and/or sales due to regulatory or quality reason.

Reviews and approves Device History Records.

Supports manufacturing and operation with establishment and maintenance of testing and inspection processes.

Gives technical quality advice in accordance with the Device Master Records.

Identifies improvements and inputs into the quality planning process.

Reviews, revises and approves documentation for consistency and compliance with good documentation practices, QMS and regulatory requirements.

Supports supplier qualification and evaluation, communication of quality issues and monitoring of trends. Supportד suppliers in resolving production quality issues and quality improvements.

Supports quality Internal audit and External audits by regulatory agencies.

Supports Document Control process and engineering changes

Leads core QMS processes such as: Non-Conformities (NCs), Failures analysis, Corrective And Preventive Action (CAPA) and SCAR processes

Supports complaint handling process

Participates in continuous quality improvement efforts through the evaluation of trends in key performance indicators, audits, and corrective/preventative actions.

Manages control of environmental conditions and pest control.

Qualifications:

BS in science or engineering or equivalent preferred.

Minimum 5 years of experience in Quality processes with SW medical device manufacturing.

Experience in leading QA processes and activities such as: Supplier Quality, production and process control.

Demonstrated knowledge of 21CFR Part 820 and ISO certification (ISO 13485 (EN ISO), MDSAP, ISO 9001)

Strong knowledge of QMS, manufacturing operations and cGMPs

ISO 13485 Lead auditor certification –advantage

Certified Quality Engineer (CQE) – advantage

Strong leadership skills

Excellent verbal and written communication skills

Proficiency in English and Hebrew.