דרושים » אבטחת איכות QA » NPI Quality Engineer

Review of Contract ,Customer SOW and SPEC requirements to ensure compliance of design and production.
Approve gates review at R&D
PLCM (Project Life Cycle Management) - process control, full partnership in project management during the development, testing, production, customer delivery and customer support phases throughout the product life
Identifying regulatory Gaps in new and carrent projects
Perform Internal and External Audits
QA presence in R&D process (capacity) and ability to prevent errors in design
Follow up after R&D corrective and preventive actions and Improvement Plans
Transfer products from development to NPI and serial production (QA activities)
Review and approval ECO / MCO / ATP/ATR, Waiver relate to R&D , ENG
Writing QA procedures
FRACAS Management
Quality Assurance Program Plan (QAPP) and the Quality Allocation Tasks for the program.
Customer complince - relate to NPI , Pre production , design errors
Perform Quarterly data analysis for QBR

we are a fast-growing global medical device company, developing and manufacturing innovative drug delivery and infusion solutions across the continuum of care- from the hospital to the home. We are looking for an excellent Production Quality Engineer to join the QA product team Job Description:
* Serve as owner of the NCMR process: manage the end-to-end handling of non-conforming materials, products, and processes, including initiation, investigation and corrective/preventive actions in accordance with company procedures and regulatory requirements.
* Monitor NCMR process including quality KPIs
* Support for non-conformity investigations and assign effective corrective actions for NCMRs and ensure timely closure and documentation.
* Perform / review Root Cause Analysis as part of NCMR process and assign relevant corrective actions.
* Act as QA representative for Manufacturing Quality process
* Conduct Quality Assurance activities such as data analysis and statistical evaluations, SOP review and approvals, audit preparation Direct Manager: Manufacturing Quality Manager

the senior product Quality Manager will provide leadership and management for the product quality passionate about customer issues. establish, maintain, and optimize an effective quality management method and benchmark to achieve high quality performance. serve as knowledge expert of product quality, leading and mentoring in identifying fundamental causes behind issues originating from manufacturing and customer blocking issues. enhance and improve products performance by proactive risk assessment and other prevention methods.
what youll be doing:
responsible for hw product quality performance at customer install base of networking switch products.
lead structured problem solving and risk assessment for quality issues arising from production and customer
maintain and supervise product health through structured routines and meaningful metrics, enabling an effective alert mechanism for early identification
responsible for customer quality issues and working within organization to resolve
passionate about improving processes to reduce client grievances and in-house waste with a strong dedication to quality
maintain and improve product build improvements, verification and validation processes, manufacturing quality to allow high quality of networking system products throughout the entire product life cycle and improvement plan.
drive for quality process improvement initiatives to minimize customer complaints and internal scrap, drive internal quality approach

we are looking for a Director, Quality QMS Compliance.
How you will make an impact:
Lead and oversee Quality Management System (QMS) activities at the Edwards Israel Innovation Center, including management review, audits, and CAPA.
Manage Quality objectives while ensuring Quality System compliance with Edwards QMS, ISO 13485 and FDA 21 CFR part 820 (QMSR).
Partner and collaborate with Operations, R&D and Project Management leaders to align and prioritize activities and to address quality issues.
Manage and mentor the Quality team, including the sub-functions of Quality Control, Document Control, and Equipment/Software V&V; foster a strong quality culture and team engagement.

Required Product Quality Manager
The Product Quality Manager is a critical role in the quality management in the space industry. In this position, youll work closely with all Engineering teams, and with Product, Program Management and Operations teams, contributing directly to our ongoing projects and initiatives.
Job Description:
Lead end-to-end quality activities across the program lifecycle, including:
Program audits
Involvement and support in internal and external project reviews and milestones
Preparation of relevant documentations and deliverables to the customer according to milestones, and customers requirements
Management of program nonconformities, alerts, and corrective actions
Support of the risk management, in coordination with the Project Management and Engineering\operations functions
Program KPIs monitoring
Support to the documentation and data control, quality records, and configuration management
Interface with customers and all stakeholders regarding program quality activities
Support operations and supply chain activities related to quality aspects, such as incoming inspection, nonconformities, and production support
Ensure program compliance with applicable space industry standards and our quality specifications.

As a Service Quality Engineer youll be the first point of contact for all service quality matters, assure key quality processes deliverables are compliant with industry standards, analyze service metrics, create and lead continues improvement projects.

Your role:

Collaborate with cross functional business and quality groups to ensure patient safety and quality requirements are met in all CT products
Review and provide quality inputs for service deliverables in NPI projects and LCM sustain projects
Perform as an expert on quality of service process deliverables and assure all deliverables are compliance
Analyzes service and markets metrics and performance indicators, preparing detailed reports that highlight trends, deviations, and areas for improvement
Assure filed work instructions are adequate and compliant
Lead cross functional projects and collaborate with markets quality and service functions to create continuance improvement