Philips Design Quality Engineer in Monroeville, Pennsylvania

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Working in the medical industry brings much fulfillment, as well as unique challenges. As part of our Health-Tech focused 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

  • Provide QA resource to product support to ensure regulatory compliance of post market products.

  • Ensure that projects to develop medical devices follow applicable company policies, procedures, standards and regulations.

  • Ensure that released devices are safe and effective and meet their intended use.

  • Assist in production and market of product in investigating and reporting the results of investigations for reported technical problems as part of corrective actions.

  • Support the investigation of vigilance and reportable events and reporting of the results of the investigations to corporate and regulatory authorities.

  • Travel to assist in customer, internal and supplier audits where required either in the US or internationally.

  • Manage auditing of internal and supplier quality systems to ensure effectiveness of the quality management system.

  • Assist in improving the culture of all staff in Quality & Regulatory requirements of the Medical Device Requirements.

  • Support the QARA Manager in quality and regulatory decisions as required and other relevant tasks as may be reasonably requested of the QARA Manager.

  • Manage safety risks associated with medical devices in accordance with applicable standards.

  • Facilitate usability analysis and activities in accordance with applicable standards.

  • Represent QA on product defect review boards, and change control boards.

  • Help coach project teams on use of quality system.

  • Prepare for and participate in project and quality systems audits and inspections.

  • Proactively participate in design reviews, quality business reviews and post market improvement teams.

  • Support the worldwide regulatory requirements through product submission, registration and continued compliance through complete life cycle of medical devices.

  • Assist in investigating and reporting the results of investigations for reported technical problems as part of corrective actions.

  • Provide risk management and design control guidance for design quality assurance activities on medical device projects and coordinate quality activities with engineering, clinical, sourcing, manufacturing, distribution, service, and support teams.

  • To support the worldwide regulatory requirements through product submission, registration and continued compliance through complete life cycle of medical devices.

  • To provide regulatory and quality input for medical device products from generation through release to obsolescence assisting in planning, developing and quality support in projects.

  • To support quality control requirements, supplier quality, complaints, post market support, audit, non-conforming materials, CAPA systems and process risk.

You are part of

This position resides in the Sleep & Respiratory Care Business Group, a business group of Philips HealthTech. We are highly dynamic, ambitious and agile within a fast changing industry.

Our vision is to work hand-in-hand with our clinical and consumer customers to transform the personalized healthcare market to meet the significant demands caused by the increase of chronic conditions and an aging society. Our mission is to improve the quality of life for consumers and patients through better awareness, diagnosis, treatment, monitoring, and management of their conditions.

Skills and experience

A person who is excited by the unique professional challenges that our Quality Transformation presents, has strong technical competencies, and demonstrates resilience challenging, often demanding situations. We are looking for a perfectionist- a fixer who continuously strives for excellence as a way of life; not just as a job. We’re looking for someone who can inspire others to adopt this mentality of prioritizing quality above all else in a relentless pursuit to improve the quality of life billions for the billions of people Philips brand touches each year.

  • Bachelor Degree in Engineering. Masters Degree preferred.

  • Minimum 2 years of experience in medical devices.

  • Knowledge of 13485 / 9001 / FDA / Canada / 14971/ standards

  • FMEA/ Root Cause Analysis/ Problem solving

  • Interaction with different functional groups.

We offer you

Enjoy endless opportunities to learn, and develop your career in the directions to which you aspire. Philips Healthcare is a place where you will work with others whose far-reaching ideas and accomplishments have impacted over 200 million lives already. Please help us determine what’s next. Your ideas and ability to deliver will help to transform the future of healthcare, and allow you to create your own legacy.

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/PhilipsChronicDisease_5.jpg . 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 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 .

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.