Careers

Title: Senior Quality Assurance Manager

Reports to: Chief Product Officer (CPO)

Division:  Commercial & Product

Position Location: Israel

The Senior Quality Assurance Manager will report to the CPO and will be responsible to monitor all company’s processes and procedures, verifying alignment with requirements and ISO 13485 and other regulatory requirements. In addition, he/she will take part in the Regulatory tasks such as FDA and CE submissions.

Primary Responsibilities:

• Opening and following up on open CAPA, working close with R&D, support, operations and supply chain on root cause investigation and opening corrective actions
• Reviewing technical drawings, production portfolios, calibration excels and vendor reports to make sure all is aligned with ISO and procedure requirements
• Maintenance of QA training schedules and effectiveness management
• Working close with R&D, Engineering, and production on approving ECO’s for new products and changes in existing ones
• QC management – before release of a new batch, verifying production is done according to procedures and going over production papers and handling non conformities (MRB)
• Conducting internal and supplier audits
• Working close with the R&D, Projects, Support and Engineering teams, including review of relevant documents
• Receiving customer complaints
• Handling equipment calibration

Position Requirements:

• BSc in Engineering / Life Science / Certified QA
• Knowledgeable on ISO 13485 and QA systems and processes
• At least 3 years of experience in Quality Assurance from the medical device industry, preferably in an FDA environment
• Experience with leading or taking part in a notified body audit
• Experience in performing internal and supplier audits, preferably having Auditor certificate
• Knowledge in DHR and DMR
• At least 1 year experience with  FDA and CE submissions – an advantage
• knowledge in regulatory processes (FDA and CE submissions)
• Highly proficient in English – reading and writing technical documents
• Highly organized, analytic, detailed, with a high level sight and understanding
• Good technical understanding and approach
• Excellent communication and interpersonal skills. Ability to influence and to deal assertively and sensitively with complex interpersonal situations
• Ability to work independently and prioritize
• Experience with Technical drawings – an advantage
• Knowledge in validation processes – an advantage