In this role, you have the opportunity to
Be a confident advisor on approval, regulatory compliance and quality management related topics, in order to achieve timely releases of innovative products that deliver high quality and outstanding reliability to the lives they will improve.
Key areas of responsibilities (KARS) for this role include:
- Ensures that appropriate quality plans are made that include all stages of the life cycle of the product and supports Quality Plan design
- 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
- 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
- Uses post-market analytics and statistics to report on product quality performance in the field (provide feedback to manufacturing, suppliers or design teams) and initiates field actions when required
- Act as a single point of contact (person assigned to project team) responsible to ensure that hardware design meets quality and compliance standards for every milestone
- Provide leadership and oversight to ensure Quality Management System Compliance
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
- 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.
- Understanding of a quality system and its development, documentation, and implementation with respect to domestic and international standards or requirements.
Knowledge of the audit process including types of audits, planning, preparation, execution, reporting results, and follow-up.
- Be able to develop and implement quality programs, including tracking, analyzing, reporting, and problem solving.
- ASQ certified Quality Engineer is a plus
- Plan, control, and assure product and process quality in accordance with quality principles, which include planning processes, material control, acceptance sampling, and measurement system.
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. Learn more by watching this video.
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.
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.
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