Quality Engineer - CAPA
PhilipsBothellUpdate time: April 8,2020
Job Description

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In this role, you have the opportunity to

Your challenge will be to guide and support Business Groups, Markets and enabling functions to always do the right thing. This involves being 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.

You are responsible for

  • Act as a Project Manager to drive CAPAs through closure with internal CAPA owners.

  • Triage and root cause investigation of newly opened CAPA Requests

  • Work with Subject Matter Experts and Element Owners as needed to gather information and investigate issues

  • Gathering data from many systems for analysis

  • Triage completed investigations for CAPA Review Board

  • Independently produces and completes CAPA record

  • Ability to assess risk as it pertains to the CAPA

  • Responsible for performing timely, detailed CAPA engineering tasks like: assessing issue descriptions, reviewing CAPA data sources, assisting with root cause analysis and quality problem solving.

  • Represent CAPAs during audits and CAPA Review Board meetings.

  • Analyze quality monitoring data sources and apply statistical techniques to identify existing and potential causes of non-conformances.

  • Perform periodic trend analysis and corrective action effectiveness measures of all quality system events and identify opportunities for improvement.

You are a part of

In Therapeutic Care, we will seek to assemble significant opportunities for future growth, entering and shaping therapeutic treatment markets through solution NPIs, connected platforms, and service and consulting models aimed to improve workflow, outcomes, and survival rates. We will also continue and enhance a relentless cultural focus on the specific quality and regulatory requirements of these segments. BG Therapeutic Care will be comprised of the two existing businesses of Emergency Care and Resuscitation (ECR) and Hospital Respiratory Care (HRC).

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

  • Bachelor’s degree in an engineering or scientific-related field or equivalent technical experience

  • 3+ years of experience within the medical device/healthcare industry and at least one year working with CAPA.

  • Able to understand and analyze complex problems, including software and hardware design issues.

  • Demonstrated knowledge of tools and techniques required to perform thorough root cause analysis and develop strong investigations.

  • Proficient with computers, including Microsoft Office suite of products.

  • Attention to detail and thorough documentation skills.

  • Ability to organize and prioritization.

  • Excellent communication both written and verbal.

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 high-reaching 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 .

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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