Quality Engineer II

Careers that Change Lives

In this exciting role as an Operation Quality Engineer, you will directly support the day-to-day Medtronic Yokneam products manufacturing, transfer, and improvements activities. You will have the opportunity to drive a culture of continuous improvement by deploying sound engineering fundamentals to achieve quality objectives and ultimately yielding better patient outcomes.

A Day in the Life

Responsibilities may include the following and other duties may be assigned

• Communicate quality standards and requirements within the organization.
• Collaborates with engineering and manufacturing functions to ensure quality standards are in place.
• Devises and implements methods and procedures for inspecting, testing, and evaluating the precision and accuracy of products and production equipment.
• Oversee and participate change approval process (risk assessment, verification, validation).
• Leads Quality Assurance and product quality improvements in cross-functional initiatives.
• Ensures that corrective measures meet acceptable reliability standards, and that documentation is compliant with requirements.
• Collaborates with global Operations, QA, Engineering and Manufacturing to ensure quality standards are in place.
• Supports day-to-day manufacturing activities.
• Specialize in the areas of production control, incoming material, product evaluation and reliability, inventory control, and development as they apply to product or process quality.
• Takes an active role in leading, and reviewing design and manufacturing changes.
• Leads product quality investigations in support of CAPA, complaints and Non-conforming material processes.
• Collect, analyze and interpret statistical data, performs analyses and provide reports as required.
• Implement new project (NPI) in production line.
• Leads Quality Assurance and product quality improvements in cross-functional initiatives
  
  

Must Haves

• Bachelor degree in mechanical, industrial or similar engineering disciplines.
• 3+ Years of Quality Assurance experience in Medical device companies or other highly regulated industries.
• Strong written and verbal communication skills (English and Hebrew)
• Strong knowledge of applicable standards and regulations standards (FDA, ISO13485, MDD)
• Auditing experience.
• Strong understanding of process validation principles, including experience with master validation plans, installation qualifications, operational qualifications, process qualifications, and test method validations.
• Vast experience with design changes, change impact assessment and design transfer activities.
• Experience in the application of risk management techniques (FMEA, FTA) in supporting of design, production and post-production activities
• Ability to work effectively in a team environment with a diverse group of people.
• Strong problem-solving skills
  
  

Nice to Haves

• Certified Quality Engineer (CQE) or other similar Quality/reilibility certifications
• Six Sigma certification
• Certified as lead auditor
• Experience in utilization of statistical techniques such as the design of experiments, hypothesis testing, SPC, etc. as part of the Quality Engineering discipline.
• NPI experience
• EUMDR and MDSAP experience
  
  

Your Answer

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Our commitment

Our unwavering commitment to inclusion, diversity, and equity (ID&E) means zero barriers to opportunity within Medtronic and a culture where all employees belong, are respected, and feel valued for who they are and the life experiences they contribute.

We know equity starts beyond our workplace, and we must play a role in addressing systemic inequities in our communities if we hope to have long-term sustainable impact.

Anchored in our Mission, we continue to drive ID&E forward both to enhance the well-being of Medtronic employees and to accelerate innovation that brings our lifesaving technologies to more people in more places around the world.

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.

Whatever your specialty or ambitions, you can make a difference at Medtronic - both in the lives of others and your career. Join us in our commitment to take healthcare Further, Together.

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.

At Medtronic, you will find a diverse team of innovators who bring their unique backgrounds and their individual life experiences to work every day. We work hard to cultivate a workforce that reflects our patients and partners, we believe it’s the only way to drive healthcare forward. We want to attract a diverse workforce, regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, veteran status, or any other characteristic protected by state or local law. Join us and bring the power of your point of view to our culture of collaboration and innovation. It is through strong diversity, inclusion, and engagement that we can remain a leader in medical technology and solutions. And by embracing everything you have to offer —your unique perspectives, talents, and contributions —we can live up to the promise of our Mission