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.
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 - from clinicians to paramedics, first responders to the ordinary person - to 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
* Engineering Degree or equivalent experience in medical device industry. * 5+ years' experience with a medical device company * ASQ certified Quality Engineer * Working knowledge of C#, Java, Python, or other managed programming language. * 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.
In return, we offer you
Sharpen your talents with new challenges in our dynamic organization. As a market-driven company, we are used 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's a calling to create a healthier society through meaningful work, focused on improving 3 billion lives a year by delivering innovative solutions across the health continuum. Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways.
To find out more about what it's like working for Philips at a personal level, visit the Working at Philips page on our career website, where you can read stories from our employee blog. Once there, you can also learn about our recruitment process, or find answers to some of the frequently asked questions.
It is the policy of Philips to provide equal employment and advancement opportunities to all colleagues and applicants for employment without regard to age, color, citizenship, disability or perceived disability, ethnicity, gender, gender identity or expression, genetic information, marital or domestic partner status, military or veteran status, national origin, pregnancy/childbirth, race, religion, sexual orientation, or any other category protected by federal, state and/or local laws. Philips is an equal employment opportunity and affirmative action employer Disability/Veteran.
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.
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