דרושים » רפואה ופארמה » Supplier Quality Engineer

Highly skilled and motivated Quality Design Engineer to join our dynamic team in the medical device industry.

The ideal candidate will have a strong background in design control, quality assurance, and regulatory compliance, with the ability to work collaboratively with R&D, Engineering, Regulatory and other teams.
Adaptable and possess a deep understanding of the regulatory landscape governing medical devices, specifically experience in all phases of product life cycle (design, development, risk management, design verification, production) in adherence with ISO13485:2016, 21 CFR 820 and ISO14971.
Main Duties:
- Lead and implement design control and production processes to ensure compliance with industry standards and regulations.
- Lead proactive design assurance activities facilitating the development and release of high-quality products.
- Collaborate with cross-functional teams to integrate quality into the design and development and manufacturing process.
- Stay abreast of evolving regulatory requirements for medical devices and ensure the company's adherence to relevant standards.
- Work closely with R&D teams to understand design requirements and provide quality engineering input throughout the product development lifecycle.
- Conduct design reviews to identify and address potential quality issues early in the process.
- Responsible for reviewing, providing input and approving product development DHF documentation (design planning, inputs and outputs, design review, V&V protocol -reports, risk analysis, and design change, product transfer to operations, etc).
- Responsible for approval of product design changes and process changes (ECO).
- Participate in Design Reviews for product teams as the quality expert, reviewer, and approver.
- Implement risk management processes and methodologies in the design and development phases per ISO 14971.
- Participate in risk assessments and develop strategies to mitigate potential risks.
- Establish and maintain quality assurance procedures to ensure product quality and regulatory compliance.
- Conduct audits and assessments to identify areas for improvement and implement corrective actions.
- Conduct Failure investigations for Complaints and CAPA.
- Responsible for approval of equipment qualification and process validation documents (pFMEA, IQ, OQ, PQ, etc).
- Perform supplier audits and provided support in preparation and performance of external audits to ensure quality and regulatory requirements are met.
- Support continuous improvement activities to reduce product failure rates.

We are looking for a Director Supplier and Production Quality.
This position will focus on improving product quality through data analysis,
investigation, issue resolution and collaboration with both internal and external parties. This person will be responsible for driving the non-conforming material process and root cause investigation through coordination with engineering & R&D organizations.
You will be responsible for making final decisions on production and supplier quality along with ensuring NPI, engineering, supply chain and fulfilment as well as production effective achievement of quality and compliance objectives.
In the role of Production & Suppliers Quality director you will oversee iTero production in various global facilities; youll also be managing suppliers and contract manufactures for iTero from around the globe.
In this role, you will:
Drive product quality improvements in production and with suppliers
Manage a team of quality engineers & the QC Dept.
Manage the NCM and MRB processes.
Lead analysis of defects data (NCM, RMA and DOA)
CAPA/ SCAR creation / resolution and maintain records as specified by the quality system
Lead QC team and drive incoming inspection improvements, such as direct- to- stock, reduction of MRB and non-conforming material inventory.
Interface with other functions on supplier related defects
Conduct root cause analysis on product quality issues, identify trends, and communicate with Engineering/ R&D on a regular basis.
Be responsible to oversee that Operations are working according to released and validated work instructions to ensure that a device conforms to its specifications.
Be responsible for process- related Validations across the company process, support SW, mold, jigs
Ensure the creation of accurate, complete and timely records and DHRs
Set the yearly suppliers audits plan and execute with the team
Be responsible for evaluating current suppliers, approving new suppliers and disqualifying suppliers
Support the introduction of iTero production lines in other facilities around the globe and with external contract manufacturers.
Work with our Global on the integration and harmonization of Purchasing controls and Production and process controls related SOPs, suppliers audits and supporting IT systems.
Support PFMEA creation and update and any other process and suppliers' risk- related activities
Additional responsibilities:
Be aware of and comply with the Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/ position.
Complete all planned Quality & Compliance training within the defined deadlines.
Identify and report any quality or compliance concerns and take immediate corrective action as required.
Support external bodies audits on- site
Perform internal audits.

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.

Required Global Engineering Manager.
Objectives:
Management of the designs teams in HQ and coordination of the engineering system activities: product engineering, manufacturing engineering, configuration engineering, electrical engineering, technology, and regulation.
Developing and implementing engineering strategies that align with overall business objectives and market trends.
Professional guidance in manufacturing engineering for various territories and ensuring that production is carried out using the same methods and standards.
Collaborating with other departments such as product management, sales, and marketing to ensure engineering efforts support company-wide initiatives.
Implementing processes and standards to maintain high-quality production of company's products.
Providing quick and accurate responses to the sales, marketing, and operations departments to meet the company's goals.
Defining and leading engineering workflows: item and product infrastructures, change management, NPI processes.
Managing workflow routines in interfaces (marketing, sales, and operations).
Setting objectives and key performance indicators (KPIs).
Member of the operations management team.
Responsible for managing the global engineering managers forum.

n this role, the QA Engineer supports products development and provides quality oversight to the R&D activities while working within a multi-functional team environment for medical devices.

The QA Engineer will play an active role to ensure the design and development process meets quality standards consistent with internal procedures and acceptance criteria, while meeting all design control and applicable regulatory requirements as well as being involved in QA activities.



Essential Duties and Responsibilities:

QA focal point for R&D projects in design and development processes.
Provide guidance on documentation structures and format to ensure compliance to procedures, relevant regulations and standards
Responsible for final approval of R&D documentation- reviewing and approving technical and DHF documentation.
Responsible for approval of product development DHF documentation (DDP, PRD, TMX, design verification & validation activities, dFMEA risk documents, test methods, protocols, reports, product design transfer)
Responsible for approval of product design changes
Finding solutions for queries within responsibility limits
Assist and provide guidance on any out of specification result, deviation, or excursion that may occur
QA representative in product development design reviews
Work cross-functionally with individuals and project or extended teams to provide guidance and ensure success of projects
Attend program meetings as required as part of extended program teams

A Global medical high-tech Company located in Shoham, is seeking a Quality Assurance and Regulatory Affairs Specialist with experience managing the development of medical devices through the approval process. The ideal candidate will have a strong regulatory and quality knowledge throughout product lifecycle with aspects of effective management and strategy.
Responsibilities & Scope of work:
Supports and maintains EU- MDR submission related activities (QMS, Technical Files, GSPR and PMS) and liaises with regulatory authorities
* Participation in internal and external audits e.g., FDA, Notified Body etc. for regulatory affairs matters - Oversight and performance of routine QA activities such as: ECO, MRB, NC, Monitoring of Calibrations, Training and Qualification, Customer Complaints, CAPA, Document and Record Control, Approval of qualification and validation activities etc.
* Control of processes in compliance with the applicable regulations and company procedure requirements - Participate in Management Reviews and analyze quality data
* Work closely with R&D through product development process and design activities.
* Support risk management activities including hazard analysis and FMEA. - Provide technical review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation.
* Identify relevant guidance documents, international standards, or consensus standards and provide interpretive assistance.
* Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents including the Medical Device Regulation (MDR), and all other standards/regulations included within applicable scope.
* Support and improve company Quality Systems by creating a quality culture and provide ongoing education on compliance activities.
* Contribute towards accomplishment of departmental and corporate goals and objectives
* All other duties as requested by his/her manager.

We are currently seeking a talented and innovative Mechanical Design Engineer to join our
engineering team. The primary responsibility of this role is the mechanical development of
sensors, focusing on design solutions using metal sheets. The successful candidate will
play a crucial role in the lifecycle of product development, from conceptual design
through integration testing and delivery to operations. This position offers a unique
opportunity to contribute to the development of cutting-edge sensor technology and to
work in a dynamic and collaborative environment.
A day in the life:
Design and Development: Design and develop the mechanical elements of our sensors, with a focus on sheet metal design. Design electromechanical enclosures and packaging. DTC for mass production solutions.
Integration Testing: Take full responsibility for the integration testing of products. Develop test plans, lead tests, and collaborate with other team members to assess performance against specifications and make necessary adjustments to designs.
Product Delivery: Oversee the transition of products from the development phase to operations and supply chain teams. Ensure that products meet all technical requirements, quality standards, and cost constraints and are delivered on schedule.
Collaboration with Subcontractors: Work closely with mechanical subcontractors to enhance productivity, meet design specifications, and ensure quality standards. This includes consulting on design, overseeing their work quality, and ensuring timely component delivery.
Production Support: Provide ongoing support for production, including troubleshooting issues in the field and implementing improvements based on feedback received from operations and end-users.
Collaboration: Work closely with cross-functional teams, including electrical engineers, software developers, signal-processing researchers, and project managers, to ensure seamless integration and alignment with required performance of the developed sensors.
Collaboration on Groundbreaking Technologies: Collaborate across company groups to explore and develop innovative technologies. Proactively contribute to cross-disciplinary projects, leveraging mechanical design expertise to drive technological advancements.

We are looking for a Design Quality Engineer.
The Design Quality Engineer is responsible for driving exceptional product quality for the patient safety, customer value beyond expectations, regulatory assurance, and optimized Cost of Quality for the Company. This is a key technical position, affecting part quality for both installed base and NPI products.
AS a Design Quality Engineer (DQE) you will plays a crucial role in ensuring the safety, efficacy, and regulatory compliance of medical equipment including cooperated with the design and development team, and apply quality management principles throughout the product life cycle.
DQE's main responsibilities include:
Review design documents and specifications, to ensure that they meet relevant standards and regulations
Participant in risk assessment, identify and reduce potential risk quality
Take part in the design and verification process

We are leading the way in high-growth area of Autonomous Driving, High-Performance Computing, Artificial Intelligence, and computer Gaming. Company is pushing the boundaries of technology in all areas. We are looking for a Mechanical Engineer in Israel office to support the product expansion that we develop towards manufacturing and product delivery.

What you'll be doing:

Accomplish robust and efficient manufacturing for design at suppliers in the area of Thermal, mechanical, from NPI stage until transfer to mass production.

Supplier readiness from the first build with mature manufacturing line, tooling readiness, stabilized yields.

Verify new supplier/technology of Thermal/mechanical parts is meeting our spec.

Manage DFM from early design stage until closure.

Analysis design and manufacturing risks and samples/prototype manufacturing.

Manufacturing line reediness: Tooling, process, fixtures, testing equipments, Automation.

Responsibility on component maturity yield, quality issues, taking manufacturing issues to closure.

Drive suppliers to excellent engineering readiness and management and supplier technology roadmap work with suppliers to have right capabilities support our requirements.

* 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