Senior QE - Quality Engineering Products and Systems

Job TitleSenior QE - Quality Engineering Products and Systems

Job Description

Senior Quality Engineering Products and Systems

In this role, you have the opportunity to

Help build a high growth business that will help improve the lives of millions of people while advancing Philips journey as a global leader in Health Technology.

Philips is one of the world's leading healthcare technology companies. We are committed to understanding the technological and human needs of patients and caregivers and to delivering solutions that enable more confident diagnoses, more efficient delivery of care, and more positive user experiences. People focused. Healthcare simplified.

The Philips Hospital Respiratory Care business has three locations in the United States. Our products include invasive and noninvasive hospital ventilators, patient interfaces, sensors, and monitoring equipment. We believe that by understanding our customers' problems we can ease the discomfort of ventilation by providing innovative solutions to improve the patient-ventilator experience, permit speech, and speed liberation. These technological breakthroughs allow the clinician to concentrate more on the patient and less on the device.

This position supports and guides a product development and sustain teams through the design life cycle, including the design transfer of the product into manufacturing, and incurring post market surveillance monitoring ensuring compliance with the Quality System Regulations, 21 CFR Part 820, and ISO 13485. An associate in this position is viewed as an active and valued contributor to the design, risk analysis, project plan, process validation, and design transfer. The associate would be required to balance business objectives and quality requirements to determine readiness of projects to proceed to the next phase. Their background in risk management would enable them to conduct safety, efficacy and hazard analysis [SHA], and failure modes and effects analysis [FMEA]. Use those analysis to drive improvement in Quality Metrics such as product development cycle time.

You are responsible for:

  • Perform technical reviews and/or develop key documents including quality and reliability plans, FMECA, design reviews, design verification and validation plans/reports, product and process validation, pilot runs and sample size justification.
  • Approve Change Request end ensure their accuracy and adequacy
  • Develop inspection criteria for components and finished devices.
  • Perform and/or coordinate supplier audits as it pertains to R&D supplier selection process. Including supplier part and process qualifications and validations.
  • Provide input to budget, planning, and evaluation processes.
  • Assist the Research and Development department to verify that; modifications to the manufacturing processes and/or product design do not affect product suitability for its intended use; assist in IQ, OQ, PQ of new equipment and processes.
  • Performs duties in compliance with relevant FDA QSRs and ISO regulations.

BEHAVIORS: The successful candidate will demonstrate:

  • Eagerness to Win
  • Take an outside perspective, serve our customers
  • Ensure speed of action and outpace competition
  • Ability to Take Ownership
  • Take Courageous Decisions
  • Has the ability to identify and solve a problem.
  • Focus on results over activity
  • Be Goal Oriented: Demonstrates high level ambition and positive attitude about long term prospects for successfully addressing new and demanding challenges.
  • Execute rigorously, see things through
  • Be Detail Mindedness: Apply the informed attention to facts and experiences that make one a highly competent, skilled expert
  • Ability to Team up and Excel
  • Have open and tough dialogues, productive conclusions
  • Collaborate
  • Learn, Improve, and Develop
  • Demonstrate Learning Agility: Aggressively learning and applying new skills/knowledge required to be successful within new, changing or uncertain conditions.

GROWTH and DEVELOPMENT: The successful candidate will:

  • Define with their manager goals for personal and professional development
  • Take accountability to execute their personal development plan to grow with in current role and to prepare for future roles.

To succeed in this role, you should have the following skills and experience

EDUCATION:

B.S. degree in an engineering discipline, Electrical Engineer degree or a related technical field or equivalent is highly desirable. ASQ (CQE, CRE, CQA) Certifications a plus.

EXPERIENCE:

3-5 years of experience as a Quality/Reliability Engineer, Design Engineer working within the framework of a Quality System. Experience with medical device manufacturing with electronic and/or electromechanical products preferred.

OTHER REQUIREMENTS:

Limited travel (0-5%). Requires demonstrated proficiency in reading, basic math and use of office standard equipment – including computer. Requires the ability to perform in a sedentary work environment (e.g. office) that may occasionally require lifting and carrying up to 15 pounds.

EOE/AA

In return, we offer you

A path towards your most rewarding career. Succeeding in this role in a complex environment will open many doors for your long term career, in other areas in Philips or otherwise. We also believe that we are at our best as a company when you are at yours as a person. Thus, we offer competitive health benefits, a flexible work schedule and access to local well-being focused activities.

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.

Find out more info about Philips at www.philips.com/na/careers

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.

#LI-

Regulatory Affairs Specialist

Great innovations start with the people that are passionate and skilled enough to create them. As a diversified health and well-being company, Philips focuses on improving people's lives through those timely and meaningful innovations.

Your challenge

We challenge you to support the Philips' as a Regulatory Affairs Specialist

Your Responsibilities:

As a core member on product development teams, the Regulatory Specialist will provide timely and valued regulatory guidance (written and / or verbal) by owning the following tasks:

  • Advise internal stakeholders (marketing, manufacturing, R&D, etc.) regarding current/pending guidance, regulations, Agency/industry initiatives, etc. to ensure regulatory strategy is in alignment with company objectives.
  • Create detailed written regulatory plans that can be used to target domestic and international shipment dates.
  • Develop and prepare product registration submissions for the US, Canada, EU and select worldwide locations.
  • Review and approve engineering changes, advertising, promotional items and labeling for regulatory compliance.
  • Identify potential regulatory approvals risks based on changes in regulations, standards country specific issues or other unique characteristics of the project.

Additionally, the Regulatory Specialist will:

  • Collaborate with worldwide colleagues regarding license renewals and updates
  • Maintain regulatory files and tracking databases
  • Communicate with regulatory agencies as needed
  • Mentor other regulatory affairs personnel when requested

We are looking for

The successful candidate will possess the following knowledge, skills education and experience:

  • Bachelor's degree required in a technical discipline.
  • Master's preferred preferably in Regulatory Affairs and/or related field (or equivalent experience in the medical device industry)
  • RAPs RAC strongly preferred.
  • ASQ certifications also desirable.
  • Minimum of 3-5 years of experience in the medical device industry (EU MDD, Health Canada, US FDA class II or class III, etc.).
  • Proficient knowledge of medical device regulations minimum FDA and Canada, Worldwide is desired. Must have personal experience with successful preparation and submission of 510(k) submissions.
  • Able to work effectively with minimal supervision
  • Proficient knowledge of domestic and international standards
  • Strong background in Design Controls.
  • Experience in supporting international registrations and/or clinical investigations.
  • Proficient computer skills in Microsoft Office Suite
  • Understand LEAN concepts, methodologies and deployment.
  • May require 5% travel annually with possibly some international.

Our offer

Here at Philips WE ARE Working Together for a Better Tomorrow:

Philips' dedication to enriching lives is reflected in our company, our solutions, and a commitment to our people. Philips products lead to improved healthcare, faster diagnosis and better patient outcomes. Philips employees change lives every day.

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.

Call to Action / Contact

Advance your career in an environment that supports work-life balance, health & well-being and continuous learning. Making a difference begins right here, where you come first.

Ready to start improving lives by putting your personal skills & passions to work?

Apply Today!

Find out more info about Philips at www.philips.com/na/careers

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.

#LI-PH1

Contact

If you forgot your password, you can click the Forgot Password button on the Sign In screen to reset it. In case of technical difficulties, please send an email to [email protected]

(Note: To ensure fairness and legal compliance in our recruitment processes, only technical issues will be monitored through the above inbox. Please do not submit resumes or applications to this email, as they will not be reviewed. Only applications received through the online application process will be considered.)


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