לוח משרות דרושים מהנדס איכות משרה מלאה, לחיפוש זה נמצאו 90 משרות

our company is an international Medical Device company that develops and manufactures innovative medical equipment. Specifically, we develop infusion pumps and their related accessory products. Job Description: supplier approval/disapproval including supplier maintenance and issuance of the Approved Supplier List. Leading the SCARS process including SCAR initiation, SCAR follow up, Supplier investigation approval including root cause analysis and SCAR closure. Leading the supplier audits process (including initial and surveillance audits) for critical suppliers, service centers, laboratories etc. by conducting on site / remote audits. Issuance and execution of the supplier audits plan including supplier audits follow up and supplier non-conformance follow up and response approval.
* Support the execution of service agreements, quality agreements with suppliers and service centers. Leading the supplier score card process, including trending.
* Serve as  CAPA Coordinator and Subject Matter Expert
* Responsible and accountable for CAPA ownership, timely execution, and effectiveness of CAPAs. This includes creation, collaboration with functional teams on Problem Statement writing/Scope identification/Risk Assessment/Containment/Correction/CAPA plans/Verification of local and global compliance to CAPA procedures to ensure timely effective closure of CAPAs Generate data and key quality trending information for use in periodic reviews like Quality Metric Reviews and Management Review for CAPA and supplier processes.
* Work within, and ensure adherence to Quality system procedures, work instructions and other Quality system requirements.
* Write, update, release, and sign quality documentation within the Quality management system
Direct manager: QA Compliance Manager

We are looking for a Process Validation Engineer to join our Operations Engineering team and play a key role in ensuring the quality, compliance, and reliability of our manufacturing processes and equipment within a global medical device environment.

In this role, you will lead and support validation and risk management activities across internal and external operations, helping ensure compliance with FDA and ISO requirements while driving continuous improvement initiatives.
You will be responsible for managing validation programs, maintaining risk management documentation, supporting audits, and collaborating closely with cross-functional teams to ensure high standards across systems, products, and processes.

This position requires a strong combination of technical expertise, analytical thinking, organizational skills, and the ability to manage multiple priorities in a fast-paced and highly regulated environment.

Success in this role means becoming a trusted subject matter expert for validation and risk-related activities, driving projects forward with a high level of ownership, maintaining strong collaboration with internal and external stakeholders, and ensuring compliance and operational excellence across validation processes.

What you will do:
Lead the creation of high-level test plans, validation assessments, and validation plans, while overseeing execution progress and completion.
Review and approve test methods, validation test plans, and validation results.
Manage validation samples and support validation execution activities across internal and external operations.
Serve as a point of contact for subcontractor test laboratories and support coordination of validation-related activities.
Maintain and regularly update pFMEA documentation and related risk management records.
Identify risks, support mitigation planning, and implement actions to maintain compliance and process reliability.
Support and conduct internal audits according to the annual audit program and report audit findings.
Manage relevant Issues, NCMRs, and CAPAs related to validation and quality activities.
Serve as a Subject Matter Expert (SME) for validation activities during internal and external audits.
Support continuous improvement initiatives related to systems, products, services, and validation processes.
Participate in and support calibration and preventive maintenance programs for measuring devices and test equipment, as needed.

Join us as a Senior Operation Quality TL, where you will lead quality initiatives to ensure operational excellence in our products and services.

Responsibilites
Lead and manage in‑process and final QC inspection activities, including supervision and professional development of QC staff.
Support and maintain the Quality Management System (QMS) in accordance with company and regulatory requirements.
Responsible for calibration management of ORBIT equipment.
Manage employee certification processes (internal and external) and develop annual training plans.
Lead and support continuous improvement initiatives in collaboration with Operations teams.
Review and approve ECO / MCO / ATP / ATR / production documentation, and waivers related to R&D and Engineering.
Lead customer complaint investigations using structured methodologies (8D, RCCA, etc.).
Plan and perform internal quality audits.
Support and participate in external quality audits and certifications (customers, FAA, CAAI, SII, etc.).
Perform and approve First Article Inspections (FAI) in accordance with AS9102.
Monitor failures and ensure effective follow‑up of corrective and preventive actions (CAPA).
Analyze quality trends and performance indicators (Quality Yield, KPIs).
Manage RMA processes and perform quarterly quality data analysis for QBRs.
Prepare Quality Plans (QP) and Quality Improvement Plans (QIP).

This role will be onsite 4 days per week, with 2 days per week in Shlomi at sister site.

In this role, The Sr Manager, Quality Engineering & Compliance is responsible for leading the sites Quality Engineering, Manufacturing Quality, and Quality Compliance functions. This role oversees engineering quality processes, design transfer, process validation, production quality oversight, customer complaints handling.

The position leads Quality Engineers for both design and operations and Quality compliance engineers and ensures that products, processes meet all applicable regulatory, customer, and corporate requirements. The Manager serves as a strong advocate for product and process quality across the full lifecycle - from design transfer and process validation through post-market surveillance.

This role works cross-functionally with Operations, Engineering, RA, Supply Chain, and external stakeholders, ensuring compliance with standards such as ISO 13485, MDR 2017/745, MDSAP, ISO 14971, 21 CFR 820, and applicable GMP requirements.

Essential Duties and Responsibilities
Quality Engineering & Manufacturing Oversight: Lead review and approval of technical and engineering documentation including: DMR, DHF elements, IQ/OQ/PQ, Process validations and qualifications, Product specifications. Risk management files (dFMEA/pFMEA), Test methods, protocols, reports, Design transfer documentation
Provide quality oversight for: New production line establishment Process validation activities Engineering changes (ECO/DCO), Software validations.
Oversee production quality controls including: Raw material approval, Calibration approval (including deviations), DHR and batch record review, Labeling release, Nonconformance management (NCMR)
Drive Right First Time and Cost of Poor Quality (CoPQ) initiatives.
Provide escalation support and structured problem-solving guidance.
Customer Complaints & Post-Market Surveillance: Lead the sites customer complaints handling process:
Investigation and root cause analysis, Risk-based evaluation, Corrections and corrective actions, RMA/RGA management, Oversee complaints trending and reporting.
Support RA in identification of Adverse Events and Hazardous Situations.
Ensure feedback loop into risk management files and process improvements.
Interface directly with customers regarding QA-related nonconformities and investigations.
Leadership & People Management; Set priorities and objectives for Quality Engineering and Compliance teams. Supervise day-to-day performance, training, and development.
Provide coaching on: Root cause analysis, Risk-based decision making, Regulatory interpretation, Technical problem solving, Ensure effective communication across functional and leadership levels.
Promote a strong Quality First culture throughout the organization.

Quality Engineer - Job Description and Responsibilities
The Quality Engineer will be responsible for supporting and maintaining quality processes across production, development, suppliers, and customer-related activities.
Main Responsibilities
Define, write, and oversee quality inspection and testing activities, including IQC, IPQC, and OQC, in both production and development environments. Manage nonconformance processes, including MRB activities, CAPA follow-up, and customer complaints. Write, update, and implement quality procedures, work instructions, and quality-related documentation. Prepare the organization for ISO 9001 audits and lead internal and external audit activities. Support supplier quality management, including supplier performance monitoring, quality issues, and corrective actions. Monitor final product and process performance, analyze quality data, and report abnormal trends or recurring issues. Work closely with Engineering, Production, Supply Chain, and R&D teams to ensure effective implementation of quality requirements. Drive continuous improvement activities to improve product quality, process stability, and compliance. Work at the Science Park in Rehovot

we are looking for an Electronics Quality Inspector - QC.
Responsibilities:
Perform quality inspections for parts and assemblies according to AS9100/ISO9001 procedures and standards.
Conduct visual inspections based on drawings and engineering requirements.
Perform in-process inspections throughout assembly and testing stages.
Identify and analyze mechanical faults and aerospace wiring system issues.
Perform First Article Inspection (FAI).
Document inspections, maintain follow-up records, and report non-conformities.

our company, a leading defense company developing and manufacturing life-saving radar systems, is seeking a student role within the Supplier Quality team. The position includes supporting Quality Assurance activities with suppliers in Israel and abroad, analyzing quality data, handling nonconformities, and supporting continuous improvement processes to ensure compliance with the companys quality requirements. Responsibilities
* Monitor supplier performance using quality metrics
* Handle nonconformance reports and quality deviations with suppliers
* Collect, analyze, and present quality data
* Maintain and update quality documents, procedures, and records in the companys systems

We are seeking a highly motivated and experienced Production and Suppliers Quality Engineer to drive exceptional product quality, patient safety, and field reliability across the Installed Base (IB). This is a key technical role supporting production stability, RMA/DOA investigations, Automated Test Equipment (ATE) performance, and cross-functional quality engineering initiatives in a regulated medical device environment.

Key Responsibilities

In this role, you will:

Support qualifications and control of ATE testers in V&V phase and production lines.

Support ECO/ECR processes, NPI projects, product updates, and cross-functional engineering changes.

Participate in supplier selection and conduct suppliers audits.

Work closely with R&D, engineering, manufacturing, and operations teams to enhance product quality and resolve technical issues.

Drive continuous improvement initiatives using tools such as Six Sigma, Lean, and Root Cause Analysis (RCA).

Support RMA/DOA processes and continuous reduction of field failures.

Ensure compliance with ISO 13485, FDA 21 CFR 820, MDR, and other applicable medical device regulations.

Maintain and support quality documentation, including CAPA, Non-Conformance Reports (NCRs), and risk management documentation.

The Quality Director will be responsible for defining, implementing, and driving quality systems, processes, and culture across the entire organization from product definition and R&D through engineering, operations, manufacturing, supplier management, and customer support.


Responsibilities:
Quality Management system
* Own and continuously improve the company's Quality Management system (QMS).
* Ensure compliance with ISO 9001 and other applicable industry standards.
* Develop, implement and maintain company-wide quality policies, procedures and work instructions.
* Lead internal and external quality audits and ensure timely closure of findings.
* Drive management reviews and quality performance reporting. Product Development Quality
* Integrate quality methodologies into the product development lifecycle.
* Partner with R&D and engineering teams to establish Design for Quality (DfQ) practices.
* Participate in design reviews, risk assessments, FMEA activities and product qualification.
* Ensure appropriate validation and verification processes are implemented. Manufacturing & Operations Quality
* Establish quality controls throughout manufacturing and production.
* Define inspection plans, acceptance criteria, and process controls.
* Monitor manufacturing yield, reliability, and field performance.
* Lead root cause investigations using structured problem-solving methodologies (8D, 5-Why, Fishbone, etc.).
* Drive corrective and preventive actions (CAPA).
* Own product quality throughout the entire product lifecycle, from product development through manufacturing and customer deployment. Supplier Quality
* Develop supplier qualification and monitoring processes.
* Conduct supplier audits and performance reviews.
* Work closely with contract manufacturers and component suppliers to ensure consistent quality.
* Drive supplier corrective actions and continuous improvement initiatives. Customer Quality
* Lead customer quality responses and investigations.
* Manage customer complaints and field quality issues.
* Support customer audits and quality assessments.
* Develop quality metrics that improve customer satisfaction and product reliability. Quality Culture & Continuous Improvement
* Promote a company-wide culture where quality is everyone's responsibility.
* Train employees on quality systems, best practices, and continuous improvement methodologies.
* Define, monitor and continuously improve Quality KPIs that drive operational excellence. Leadership
* Build and mentor the Quality organization as the company grows.
* Collaborate across R&D, Engineering, Operations, Supply Chain and Executive Leadership.
* Serve as the company's quality advocate internally and externally.