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Required Quality Sys Eng - P4
Yokneam, Israel
ID: 577277
Main Duties:
Member of integrated product team (IPT)- responsible for supporting activities required to ensure quality of the design though compliance with design controls.
Lead proactive design assurance activities facilitating the development and release of high-quality products.
Review and approve product design document- in accordance with design controls standards and companys policies. This includes but is not limited to design verification and design validation activities.
Parenting with R&D- ensures design control processes are maintained and continuously improved to ensure on-going compliance to all applicable regulation and standards.
Assure proper documentation and execution of design planning, inputs and outputs, design review, V&V, risk analysis and design change per company and regulatory requirements.
Support audits and compliance assessments of DHF and other program files to ensure quality and regulatory requirements are met.
Partnering with R&D, RA, Clinic affairs and BU, ensure that pre-release elements of risk management activities are properly conducted and included within the applicable risk management file.

Required Quality Engineer Production
Beit Shean
Description:
Executed risk analyses with control plan (PFMEA)
Plan, control, and assure product and process quality in accordance with quality principles
Implement effectively, professional tasks in the areas of quality assurance and regulations.
Oversee production quality processes, including contract manufacturers.
Support company failure investigation, CAPA, MRB, audits as required
Define and implement KPIs for the internal teams in Quality reliability and functionality .
Perform periodic analysis of KPIs and build improvement plans.

* Executed risk analyses with control plan (PFMEA)
* Plan, control, and assure product and process quality in accordance with quality principles
* Implement effectively, professional tasks in the areas of quality assurance and regulations.
* Oversee production quality processes, including contract manufacturers.
* Support company failure investigation, CAPA, MRB, audits as required
* Define and implement KPIs for the internal teams in Quality reliability and functionality .
* Perform periodic analysis of KPIs and build improvement plans