Job Title Senior Quality Engineer-Hardware/Software

Job Description

In this role, you have the opportunity to

A Senior Quality Engineer within our Emergency Care and Resuscitation (ECR) team is responsible in developing and implementing systems to ensure products or services are designed and produced to meet or exceed customer requirements and expectations. The engineer participates in the cross-functional change management process to assure the products or services continue to meet customer requirements. The engineer provides independent oversight and review of the project deliverables throughout the product lifecycle. The engineer provides leadership and is responsible and accountable to the organization for own decisions and actions, while also holding others accountable for the same.

This position will have a focus on software based quality assurance both in design and manufacturing.

Working in the medical industry brings much fulfillment, as well as unique challenges. As part of our HealthTech cused company, you will be responsible for successfully dealing with and managing Philips relationships with approval agencies such as the US Federal Drug Administration (FDA).

You are responsible for

• Ensures that appropriate quality plans are made that include all stages of the life cycle of the product and supports Quality Plan design with an emphasis on software validation and design controls.
• Validates key design inputs like: usability, reliability, performance, supportability, manufacturability, localizability, safety, security, privacy, serviceability, sustainability and costs
• Provides effective oversight of the execution of the Quality Plan , any Risk Management activities, and of all design related activities during the product/system lifecycle with an emphasis on software.
• Performs independent technical assessment on product quality performance and post-market product quality analysis
• Can Lead quality related problem solving and root cause analysis during design and manufacturing
• Act as a single point of contact (person assigned to project team) responsible to ensure that software based design meets quality and compliance standards for every milestone
• Function as a local subject matter expert on software validation techniques and management of electronic records and signatures.
• Provide leadership and oversight to ensure Quality Management System Compliance

You are a part of

Emergency Care and Resuscitation is a key business along the continuum of care, and has a broad product portfolio of advanced life support solutions, automated external defibrillators, and data management solutions. Our mission is to design, produce, and deliver every solution as if the life of someone we love depends on it. Every day, we empower and enable our customers om clinicians to paramedics, first responders to the ordinary person save lives using our innovative, market leading technology. We are searching for passionate leaders to join us as we strengthen our product portfolio, expand our services and solutions, and bring game changing technology to market.

To succeed in this role, you should have the following skills and experience * ASQ certified Quality Engineer

• Engineering Degree or equivalent experience in medical device industry.
• 5+ yearsperience with a medical device company
• Have an understanding of quality philosophies, principles, systems, methods, tools, standards, organizational and team dynamics, customer expectations and satisfaction, supplier relations and performance, leadership, training, interpersonal relationships, improvement systems, and professional ethics.
• Have understanding of a quality system and its development, documentation, and implementation with respect to domestic and international standards or requirements.
• Be able to develop and implement quality programs, including tracking, analyzing, reporting, and problem solving.
• Be able to plan, control, and assure product and process quality in accordance with quality principles, which include planning processes, material control, acceptance sampling, and measurement systems
• Multiple years of experience working in a software design and quality assurance environment
• Demonstrable experience validating software in a manufacturing environment.
• Familiarity with C and C++

In return, we offer you

Sharpen your talents with new challenges in our dynamic organization. As a market-driven company, weused to listening to our customers & apply the same thinking to our employees. We offer a competitive salary, outstanding benefits and flexibility in a career with a positive and supportive atmosphere in which to develop your talents further.

Why should you join Philips?

Working at Philips is more than a job. It calling to create a healthier society through meaningful work, focused on improving 3 billion lives a year by delivering innovative solutions across the . Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways.

To find out more about what itike working for Philips at a personal level, visit the on our career website, where you can read stories from our . Once there, you can also learn about our , or find answers to some of the .

Philips is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex (including pregnancy), sexual orientation, gender identity, national origin, genetic information, creed, citizenship, disability, protected veteran or marital status.

As an equal opportunity employer, Philips is committed to a diverse workforce. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants that require accommodation in the job application process may contact 888-367-7223, option 5, for assistance.

Contact

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