Philips QA Engineer in Mount Pleasant, Pennsylvania

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Scope

This position has responsibility to provide Quality Engineering support to the Sleep & Respiratory Care (SRC) organization in the areas of Service QA (distribution, service, customer service) to ensure that products, processes, and projects are in compliance with the Quality Management System, Philips Policies, and Quality System regulations. Primary responsibilities include:

  • Provide oversight of Q&R supported Customer Services projects ensuring timely completion of project deliverables, correcting issues delaying completion and reporting on status of projects.

  • Collaborate with Supplier Quality on processes related to the acquisition of purchased services,solutions, or other activity that impacts the Quality Management System to ensure vendor assessment and set ups are complete.

  • Leading and supporting continuous improvement initiatives

  • Conduct quality systems’ audits (process, QMS, supplier) in support ofdepartmental needs.

  • Lead and participate in special projects as assigned by Manager.

  • Reports to the Head of Service QA and will work cross functionally with areas such as Distribution, Service, Supplier QA and engineering.

Key Responsibilities

  • Provide quality assurance guidance in support of process or product investigations.

  • Understand process validation methodologies, IQ/OQ/PQ to ensure that equipment/ process changes are robustly transferred to operations.

  • Support the implementation of quality improvement initiatives across the service QAteam and functional areas.

  • Responsible for conducting quality audits ofproviders and sites of purchased services to ensure compliance with regulations and standard and to identify and implement improvement opportunities within the organization

Business Requirements

  • Bachelor's Degree in Electrical/ Mechanical Engineering, Science discipline or related field preferred.

  • At least 2years' experience in Healthcare, Medical Device or related industry experience with demonstrated understanding of and ability to interpret regulations and guidelines governing medical devices, including CFRs, ISO 13485, EN 46001, and the MDD.

  • Demonstrated understanding and experience in applying modern quality assurance and control tools (statistical analysis , acceptance sampling, DOE , gauging and gauge R&R , Statistical Process Control ).

  • Demonstrated ability to manage/coordinate investigations and continuous improvement projects.

  • Excellent technical writing, communication, and organizational skills required, experience with MS Office products required.

  • Excellent oral and written communication and interpersonal skills, ability to work independently and complete multiple assignments on time, required.

  • SAP experience preferred.

  • Ability to travel internationally (U.K.) several times per year.

Key Competencies

Deliver Results: hold self-accountable, acting with urgency and resilience to deliver on commitments.

Commitment to Quality - Demonstrates an understanding of the Quality System requirements and is focused on ensuring their work and the work of those around them adhere to quality standards/goals.

Goal Orientation - High level ambition and positive attitude about long term prospects for successfully addressing new and demanding challenges.

Drive Operational Excellence: Collaborate End2End and share knowledge and ideas with a real drive to get things done faster, more effectively and with increase quality.

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.

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