לוח משרות דרושים מנהל איכות | מנהל QA במרכז

The ideal candidate will have 4-5 years of experience in the medical devices industry, managing quality processes in development/production and others.
Managed 1-4 team members. Critical thinker who will proactively improve the quality systems of the company through internal audits, participation in process improvement programs, and interaction with key partners to obtain constructive feedback. 
Responsibilities:
* Providing management and control of the Quality Assurance processes
* Experience in team management
* Initiate, monitor, and verify the effective implementation of the Quality Management system (QMS) in all areas of company activities.
* Identify potential risks before they become a problem, focusing on root cause analysis and preventive action.
* Vast knowledge in ISO13485/21CFR, MDR
* Managed and led external audits and worked with notified bodies.
* Manage and perform internal and external quality audits and inspections and compile detailed reports of findings.
* Manage the quality aspects of the manufacturing and clinical processes including feedback, complaints, and technology malfunctions and failures.
* Manage suppliers' evaluation and approval.
* Ensuring all processes are controlled and monitored.
* Documenting new and existing processes
* Training and mentoring company employees and sub-contractors on the quality management system
* Maintains the quality infrastructure of the company.

Required QA Manager
Position Overview:
The QA Manager is a senior QA professional who leads a team of QA engineers. They are responsible for overseeing the team's work on software patches, reproduction scenarios, automation development, troubleshooting, and analysis for future enhancements and QA road-mapping. This role involves handling complex customer issues, coordinating with development and support teams, and ensuring compliance with evolving releases, policies, and procedures. The ideal candidate should be a fast learner, able to adapt quickly to changing technologies and work procedures to provide top support and solutions for our product.
Position Description:
Lead a team of QA Engineers providing expert-level technical QA services.
Manage the team's daily operations and employment procedures.
Analyze, diagnose, and debug complex customer issues.
Verify and implement patches, fixes, and diagnostic tools.
Take ownership of patch verification and drive towards resolution.
Design and implement work methods and habits to improve product reliability.
Collaborate closely with Escalation Engineers.
Raise critical issues within the product from tickets or QA routines.
Conduct root cause analysis to enhance product and team efficiency.
Foster cooperative relationships with other internal groups.
Coordinate with engineers from various products to deliver success.
Acquire broad and in-depth product knowledge.
Create and improve documentation to train QA engineers.
Typical Responsibilities:
Manage, lead and mentor a team of QA engineers
Monitor ticket queues to ensure escalations are assigned.
Ensure support escalations are processed in a timely manner from QA aspects.
Drive and ensure a high-quality bar of tests execution and documentation, test results, bugs, and bugs validation (quality life cycle)
Drive and control both manual testing and automated debugging
Provide post-escalation analysis for root cause and preventative actions.
Create and follow up on preventative actions to reduce escalations.
Collaborate with other escalation engineers on projects.
Keep team members informed about product development and roadmap.
Conduct 1-on-1s, daily syncs, and sync with Escalation Managers.
Set goals and tasks for each QA engineer based on their technical level.
Participate in team meetings with Escalation Engineering, dev, and other stakeholders.
Coordinate work and escalation assignment with development during escalation load.

For a company in the field of med-tech,
dynamic company specializing in the design, development, and manufacturing of innovative medical devices for the inhalation of plant substances.

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.

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 a

Required Customer Support and Quality Manager
As a Customer Support and Quality Manager, you will be at the forefront of ensuring our customers receive unparalleled service and support.
Your role will be critical in maintaining high product quality standards and fostering strong customer relationships.
You will work closely with our development and solution management team to relay customer feedback and ensure our solutions continuously meet the evolving needs of the agricultural sector.
Responsibilities:
Lead and manage the customer support team to ensure timely and effective resolution of issues and inquiries.
Collaborate with the product development team to integrate customer feedback into product enhancements and new features.
Establish key performance indicators (KPIs) for customer service excellence and quality assurance, and report regularly on these metrics.
Hire, coach and direct support engineers; mentor on support best practices to team members and colleagues
Oversee the customer feedback loop, ensuring all feedback is acknowledged, analyzed, and acted upon.
Manage customer satisfaction surveys and implement strategies for continuous improvement.
Act as a key point of contact for major clients, building strong relationships and ensuring their needs are met with the highest standard of service.

The QA Lead will manage a group of QA Engineers working in the development Agile teams and will be involved in all the phases of the products life cycle, from the design to the delivery and to the operation and maintenance. QA Lead will work closely with our Product department providing R&D feedback to the product requirements and verifying that the features are developed as per their PRDs. This position requires about 80% of hands-on involvement in tests automation, documentation and other daily QA activities.
 Location:
Petah Tikva, IL