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In this role, you have the opportunity to Collaborate with cross-functional team with other business and engineering disciplines in the change management process to assure the products or services continue to meet customer requirements. You are responsible for:
Develop and implement quality programs, including tracking, analyzing, reporting, and problem solving.
Provides effective oversight to the execution of the SW Quality Plan and any Risk Management activities
Validates key design inputs like: usability, reliability, performance, supportability, manufacturability, localizability, safety, security, privacy, serviceability, sustainability and costs.
Provide oversight of Manufacturing New Product Development/NPI projects ensuring timely completion of project deliverables, correcting issues delaying completion and reporting on quality system status of projects on manufacturing department or site level
Plan, control, and assure product and process quality in accordance with quality principles, which include planning processes, material control, acceptance sampling, and measurement systems.
Plan, control, and assure product application, including design, manufacturing and construction.
Have knowledge of reliability, maintainability, and risk management, including key terms and definitions, modeling, systems design, assessment tools, and reporting.
Have understanding of a quality system and its development, documentation, and implementation with respect to domestic and international standards or requirements.
Have an understanding of the audit process including types of audits, planning, preparation, execution, reporting results, and follow-up.
Acquire and analyze data using appropriate standard quantitative methods across a spectrum of business environments to facilitate process analysis and improvements.
Provide quality support and input on development and test of software.
Develop inspection and test strategies.
Reviews and assists in the development of verification and validation protocols and reports and identifies gaps for compliance with internal processes.
Author validation, verification, and inspection assessments to ensure the defensibility of product test data. Selects appropriate testing sample sizes based on criticality and statistical calculation.
Participates on teams to ensure robust application of appropriate design and manufacturing controls.
Supports leadership to ensure quality and completeness of project design history files, risk management files, validation packages, and change orders.
Provides ongoing quality engineering support throughout the product lifecycle, including risk management, design and manufacturing changes, and CAPA investigations.
Engages in continuous improvement activities by identifying opportunities and recommending improvements to design and development process.
To succeed in this role, you should have the following skills and experience
Engineering Degree or equivalent experience in medical device industry.
At least 5 years’ experience in with Medical Devices.
Software Validation/Verification for regulated, embedded software/systems and processes.
Experience in Software quality for standalone and embedded software.
Understand risk analysis philosophies, methodologies, and their applications.
Have a working understanding of LEAN and six sigma concepts, methodologies and deployment.
Be able to make tough, decisive decisions concerning the containment and disposition of product quality and product safety issues.
ASQ certified Quality Engineer desired
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 at http://www.philips.com/b-dam/corporate/corporateblog/2016/PhilipsChronicDisease5.jpg . 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 at http://www.philips.com/a-w/careers/healthtech/working-at-philips/working-at-philips.html on our career website, where you can read stories from our employee blog at http://www.usa.philips.com/a-w/our-people/life-at-philips.html . Once there, you can also learn about our recruitment process at http://www.philips.com/a-w/careers/healthtech.html , or find answers to some of the frequently asked questions at http://www.philips.com/a-w/careers/healthtech/faq.html .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.#LI-PH1
