Vice President of Quality

Managerial responsibilities

·Part pf company’s Staff, reporting to GM.

·Manage QA’s short term and long term planning and activity

·Manage QA department

·Strategy building – 1 and 3 Years plan

·Manage QA budget

·Build quality monitors for the company management

Professional responsibilities

·Responsible for managing quality systems, processes, and procedures to assure product quality and safety.

·Management representative for the company’s QMS

·Overview, follow up and guidance of routine QA/QC activities such as CAPA, NCMRs, ECO, SCAR (customer compliant), incoming inspection, in process inspection, final inspection, product release.

·Provide guidance to product development teams as to the required deliverables to ensure compliance throughout product development cycle.

·Responsible for engaging strong interdepartmental and cross-functional/organisational relationships to drive quality system requirements.

·Communication with regulatory and certification agencies

·Responsible for Internal audits and suppliers' audits, certify suppliers to required standards. Lead external audit preparation

Job Requirements:

·Education: A degree in science / Engineering – an advantage

·Job Skills:

oAt least 10 years of work experience in the QA field

oAt least 5 years experience as a manager

oQA management experience in a medical device company – a must

oSolid experience in ISO and external Audits

oExperience in working with medical device standards

oExperience in working with manufacturing companies – an advantage

oClean room and sterilization understanding –a n advantage

Experience in combination device field and working with Pharma companies- an advantage