Senior Supplier and Design Quality Engineer

Marketing      ·       Yokneam, Industrial Zone, HaTsafon, Israel       ·       Full time

Locations: Yokneam, Industrial Zone, HaTsafon, Israel

Job ID: 22000MQZ

Job Description

Careers that Change Lives

We’re a mission-driven leader in medical technology and solutions with a legacy of integrity and innovation. Be a part of a community of experts committed to ensuring quality, affordable healthcare worldwide.

Come strengthen your specialized skills and enhance your expertise. We’ll support you with the training, mentorship, guidance, and networks you need to advance, and empower you to work in the way that’s best for you.

Together, we can confront the challenges that will change the face of healthcare. Join us for a career that change lives.

A Day in the Life

As a Senior Supplier and Design Quality Engineer, take an active part in the development of the company’s products, by ensuring that design control is properly maintained and executed, you will monitor changes to current product designs, follow the corresponding requirements set forth by local procedures, regulatory authorities and notified bodies

Responsibilities may include the following and other duties:

• Develop and manage the process that establishes and maintains quality assurance and regulatory programs, policies, processes, procedures and controls to ensure that the performance and quality of products conform to established standards and agency guidelines.
• Mentor and coach, Design quality assurance, R&D in Regulatory and Industry best practices in Design and Development related procedures.
• Review and approve product Verification and Validation strategy
  Review and approve design documents and processes in accordance with Design Controls standards and company’s policies.
• Lead process improvement projects and conduct training with Quality
• Support DQA during external inspections and participating in the management of external inspections as required.
• Prepare management reports depicting trends and useful data for management review purposes.

Other activities may include:

• Reviews Design Change Process.
• Support RFAI and interactions with worldwide competent authorities & notified bodies.
• Drive QMS & product continuous improvement through CAPA process, CAPA investigations, CAPA & compliance audit trending of quality data streams
• Evaluate corrective and preventing action responses to the assessment findings for adequacy, including root cause and timeliness. Elevate issues to management, as appropriate.
• Lead  or take part complaint investigation and analysis

Must Have:

• Bachelor’s Degree in Engineering or Science field with 5+ years relevant experience, or master’s degree in engineering or Science field with 3+ years relevant experience.
• Working knowledge of the FDA Quality System Regulation 21CFR 820, 21CFR Part11, ISO13485, ISO14971 and the Medical Device Directive MDD/MDR

Nice to have:

• Previous experience working in a cross-functional team environment

About Medtronic

Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life.  We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.

We want to accelerate and advance our ability to create meaningful innovations – but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future. 

PHYSICAL REQUIREMENTS

The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer and communicate with peers and co-workers.

Travel:  No

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