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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.

We are seeking great talent to help us build The DNA of tech.
Our company manufactures one of the worlds largest portfolios of discrete semiconductors and passive electronic components that are essential to innovative designs in the automotive, industrial, computing, consumer, telecommunications, military, aerospace, and medical markets.
We help the worlds most in-demand technologies come to life.
Every day our products touch your life and the lives of people across the world.
Come join us and help us build The DNA of tech.
Our company is a Fortune 1,000 Company listed on the NYSE (VSH).
Our company in Dimona is currently seeking applicants for a Engineer to QA Department.
You will be responsible for ensuring the final product before it is released meets the companys standards of quality in terms of functionality, performance, reliability, and usability.
Our company provides its employees with support, a variety of tools for personal growth and a wide range of opportunities and advanced career within the company.
Our company is a stable and solid company which has served as home and family to thousands of its employees for many years.
What you will be doing:
Create, document, and track corrective action reports like 8D reports (both customer and internal).
Communicate with customer representative/ Sales / Marketing regarding Customer complaints and customer quality questions.
Work with process engineering personnel and other departments regarding problem root cause analysis, corrective and preventive actions.
Analysis of problem trends and drive continuous improvement actions.
Creates and/or maintains various reports as needed.
Support physical analysis of failures in Failure Analysis Lab.
Performs supplier audits against an established schedule, occasional travel may be required.
Assists in ISO 9001, IATF 16949, ISO 13485, VDA 6.3 and internal audits.
Supporting and interacting with customers through complaint investigations, resolution, and trending.
Track corrective actions and verify the effectiveness of the corrective actions.
Additional duties or functions may be assigned by manager.
What can we offer you for your talent:
Our company offers a comprehensive suite of benefit programs and other resources designed to help you achieve your personal and professional goals.
With us, youll experience unique career paths, an open and collaborative culture, a stable business that will be there for you, and opportunities to work globally and locally.

We are seeking a highly skilled QA and Design Control Manager with proven experience in the medical devices industry to join our team and contribute to the effective maintenance of our (MDR) ISO13485 certified Quality Management System and move us ahead with implementation of QMS that is compliant with FDA 21 CFR Part 820 regulation.
Key Responsibilities:
Responsible for managing or governing all QMS-related processes per ISO 13485 standard e.g., CAPA, Nonconformance, Changes, Complaints handling, Recalls, Data analysis, Risk management.
Assuring production line compliance and working closely with the QA at the contracted manufacturer.
Ensuring compliance with in-house procedures through ongoing, periodic audits or inspections.
Provide professional QA and Regulatory guidance throughout the entire product lifecycle: from the early feasibility through planning, and development until the post-marketing stages.
Guidance by the Design and Development requirements per ISO13485 and Product Realization.
Maintaining design control activities by ISO13485.
Ensuring validation processes are performed and documented.
Provide support for risk analysis processes and technical file maintenance.
Working closely with the Medical Engineering team and R&D team
Making the quality world accessible to the Engineering and R&D team
Reports directly to the VP of Regulatory Affairs & QA

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.

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.