Description
The Quality Assurance (QA) Manager will be responsible for creating and maintaining a Quality plan and quality management system (QMS) which will be compliant with FDA, CE and ISO 13485 guidance and standards. The QA Manager will ensure that quality standards are being met and any deviation from an applicable protocol, standard or guideline has been adequately investigated and addressed. The QA Manager will provide all needed training and make the organization inspection ready at any moment. Management responsibility will include the QA and Quality Control (QC) team, as they are constructed in the Company.
The QA Manager will report to the Company’s CEO or VP RA&QA.
Responsibilities
- Drive a QA culture change in a company that is not yet QMS compliant.
- Develop and implement a quality strategic workplan for the QMS according to FDA, CE
and ISO 13485 requirements to successfully support research and product development, manufacturing and post marketing surveillance. - Prepare the company for ISO13458 certification.
- Provide QA and QC leadership/mentorship to ensure QMS areas are adequately
supported and resourced. - Provide leadership and support for any internal, customer, regulatory body, or health
authority audits/inspections and maintain a state of readiness for inspections in all
departments. - Lead and/ or support compilation and investigation of non-conformances with the
implementation of best-practice corrective actions and preventive action plans (CAPAs). - Oversee and drive refinement of training program requirements, document control and
supplier quality activities to build in increased effectiveness.
Position Requirements
Education
- MSc or PhD in life Science or engineering.
Experience and Skills Required
- Experience in implementing and/or maintaining quality management systems in a
diagnostic or Medical Device company. - Experience driving a cultural change from an R&D to a manufacturing environment
- Proven ability to interact with all levels of colleagues to educate and inform on the utility
of the QMS, to drive compliance and continuous improvement. - Experience managing QA and QC teams
- Proven ability to lead cross-functional teams in problem-solving and execution.
- Excellent Hebrew and English communication skills
- Computer proficient with multiple software programs, including MS Office Suite, and
Laboratory Management Systems
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