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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.

As Supplier Quality engineer, you will have responsibility for leading our quality assurance day to day quality activities and projects. This role provides quality support for operations, manages our contract manufacturing suppliers (quality/eng. oriented) and ensure the overall quality o four manufactured products, support and monitoring the production and processes to meet high quality standards. You will also be the leader in defining and implementing quality systems and processes to drive continuous product and process improvement.
Responsibilities:
Day-to-day quality engineering activities such as product quality documentation, customer complaints, ECOs, product deviation, non-conformities, FAI, Document control and fields corrective action.
Manage/Support investigations of escalation, deviations, CAPAs, risk assessments, FMEA, root-cause analysis activities internal or supplier sites.
Responsible for leading and implementing IPQC, IQC, OQC approval to supplier.
Collect, analyze, and interpret statistical data, perform analyses, and provide reports as required.
Actively involved in the NPI process
Leading and continuously improving companys Quality Management System and quality engineering activities, Monitor, and analyze quality performance and KPI.
Develop and maintain successful external auditing plans for Suppliers and their 2nd tier.
Collaborate with Operations, R&D QA, Engineering and Manufacturing functions to ensure quality standards are in place.
Takes an active role in leading, reviewing, and approving quality manufacturing product changes.
Validation of manufacturing process to meet targets, production output and quality standards.

* 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