לוח משרות דרושים הייטק אבטחת איכות QA בשרון

The Senior Specialist, Quality System Engineer will ensure the West IL Quality Management System consistently meets the regulatory, enterprise and customers requirements. The Senior Specialist, Quality System Engineer will be responsible for developing and implementing continuous monitoring and improvement of the Quality Management System according to applicable regulatory requirements- MDD 93/42/EEC, Medical Device Regulation (MDR) 2017/745, 21 CFR 820, MDSAP, ISO 14971, ISO 13485 etc. and will make sure the QMS is maintained and effective . Senior Specialist, Quality System Engineer will provide support with the analysis of quality issues to identify root causes and implement corrective action to reduce risk of quality failures.

Essential Duties and Responsibilities:



The Sr. Specialist, Quality System Engineer will have an in-depth knowledge and experience of the applicable regulatory requirements and will make sure those are implemented throughout the quality management system, maintain the quality system procedures by verifying their compliance to relevant regulatory requirements, lead quality related matter regarding MDR and other regulatory requirements.
Responsible for the sites internal audit program- managing the internal audit plan as per applicable regulatory requirements, lead audits, collaborate with additional auditors, maintain the pool of auditors, review and approve audit reports, set corrective actions and perform follow ups, as well as ensure nonconformances/deviations/complaints are investigated and assessed for root cause and identification and closure of effective CAPAs
Lead and perform risk-based approach (risk assessments) processes and implement control plans.
Responsible for site improvement projects related to Quality processes such as (but not limited to- Data integrity, Lean/Six Sigma projects, CoPQ/cost reduction, etc.).
Responsible for the QA approval of employees training files and approval of employees qualification certificates.
Responsible for the sites metrics and KPI data collection and analysis, including weekly, monthly (including MBR) and routine reports, both internally and externally. Collaborate with both internal and external stakeholders in relation to metric reporting. Identify trends in applicable areas, analyze, evaluate and initiate applicable actions to mitigate, and for presenting the data during Management Reviews
Responsible for the sites procedures alignment with applicable West Enterprise procedures.
Interact and collaborate with Laboratory; Operations, Engineering, R&D, RA, D&T and other functions to support resolution of Quality issues and investigations.
Maintaining the quality system procedures by verifying their compliance to relevant regulatory requirements.
Lead the activities to Identify and verify quality agreements with Economic Operators are up to date with the state of the art EU/US and ROW regulatory requirements along with references to the applicable SKU and distribution zones to the relevant customer/EO

you'll be part of a dynamic global team committed to redefining the financial services sector through technological innovation. You will contribute to creating safer financial environments and have the opportunity to work with some of the brightest minds in AI, ML, and financial technology. We offer a collaborative, inclusive, and forward-thinking work environment where your ideas and contributions are valued and encouraged.
Join us in our mission to revolutionize the financial world, making it safer and more trustworthy for millions worldwide. Explore exciting career opportunities at where innovation meets purpose.
We are looking for a Director of QA to join our innovative R&D department.
As the Director of QA, you will spearhead the development and execution of a comprehensive QA strategy that aligns with our company's overarching goals and vision.
Your role will involve mentoring a team of QA managers and engineers and fostering a collaborative and innovative environment while ensuring continuous improvement.
Additionally, you will closely collaborate with cross-functional teams to seamlessly integrate QA initiatives throughout the product lifecycle, ensuring the delivery of high-quality products that meet industry standards and compliance requirements.
Key Responsibilities:
Leadership and Strategy.
Develop and implement a comprehensive QA strategy aligned with the company's overall goals and vision.
Led and mentored a team of QA managers and engineers, fostering a culture of collaboration, innovation, and continuous improvement.
Collaborate closely with cross-functional teams, including software development, product management, and customer support, to ensure QA initiatives are integrated seamlessly throughout the product lifecycle.
Quality Assurance
Establish and enforce QA processes and standards that adhere to industry best practices and compliance requirements.
Design, implement, and maintain test plans, test cases, and test automation to thoroughly validate the functionality, performance, and security of our products.
Conduct risk assessments and develop mitigation strategies to identify and address potential product quality issues.
Test Automation
Drive the implementation and expansion of test automation frameworks, tools, and methodologies to enhance testing efficiency and coverage.
Champion the adoption of continuous integration and continuous delivery (CI/CD) practices to facilitate rapid and reliable product releases.
Quality Metrics and Reporting
Define and track key quality metrics and key performance indicators (KPIs) to measure the effectiveness of QA efforts.
Prepare and present regular quality status reports to senior management, highlighting the test coverage, achievements, challenges, and action plans.
Innovation and Learning
Stay current with industry trends, emerging technologies, and security threats to drive innovation in QA processes and methodologies.
Encourage a culture of continuous learning and professional development within the QA group.