Philips Quality Engineer in Mount Pleasant, Pennsylvania
This position has responsibility to provide Quality Engineering support to the Sleep & Respiratory Care (SRC) Distribution and Postponement operations located in Youngwood, PA and the UK, to ensure that products are warehoused, configured, and released with a high level of quality, while maintaining compliance with Quality System Regulations. In addition, this position will partner with other Philips quality systems that interface with the SRC QMS to ensure regulatory compliance and will be an active member of distribution/postponement projects to assure quality system compliance. You will report to the QA Team Leader, Distribution & Service and will work closely with the distribution organizations as well as other QA functions and engineering.
Key Areas of Responsibility
Ensure compliance with Quality Management System, in accordance with Philips Policy, applicable worldwide regulations and standards (FDA/ISO)
Review and approval of procedures, change notices, and other supporting distribution/postponement documentation.
Provide technical guidance in support of process or product investigations.
Review and approval of equipment (tooling files), process validation (MVPs and IQ/OQ/PQ protocols and reports), software validation, and process risk documentation to ensure compliance.
Support the implementation of continuous improvement initiatives across the distribution organization.
Facilitation and support of LEAN deployment, including development of departmental KPI metrics, CommCells, and dashboards.
Collaborate with Business Quality, Manufacturing, & Design organizations to assure E2E process/product continuity.
Facilitate and/or Participate on special projects as assigned by Manager.
Work with supplier quality on processes related to the acquisition of purchased services, solutions, materials, components, sub-assemblies, and completed products and to ensure vendor assessments are completed.
Bachelor's Degree in Engineering, Science Discipline, or equivalent preferred.
At least 3 years experience in Healthcare, Medical Device or related industry 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 , S tatistical Process Control, Process Validation, and Change Control ).
Demonstrated ability to manage/coordinate Investigations, CAPAs, Continuous Improvement projects, and LEAN efforts.
Excellent technical writing, communication, and organizational skills required.
Excellent oral and written communication and interpersonal skills, ability to work independently and complete multiple assignments on time, required.
Experience with MS Office products required.
SAP experience preferred.
Ability to travel internationally (U.K.) several times per year.
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.