Philips Quality Engineer in Highland Heights, Ohio
As the Quality Engineer within the Refurbished Systems business your challenge will be to guide and support Business Groups, Markets and enabling functions to always do the right thing. This involves taking the lead to continuously raise the compliance maturity of the organization on quality management related topics, support LEAN initiatives and Circular Economy, and the release of innovative products that deliver high quality and outstanding reliability to the lives they will improve.
Ensure compliance with all U.S. and applicable international regulatory requirements pertaining to product approval, marketing, and labeling. Plan and direct establishment of quality assurance standards. Responsible for the application and maintenance of quality standards as they apply to products and services of the company both nationally and internationally.
Key areas of responsibilities (KARS) for this role include:
Initiate, implement, and maintain necessary processes for the quality management system to ensure compliance to applicable standards and regulations.
Maintain quality system records to ensure compliance to applicable standards and regulations.
Management of submitted document request which includes processing, reviewing, obtaining approvals, and publication.
Administer Training Management System assignments related to QMS changes and conduct employee trainings.
Plan, prepare, execute and report internal audits and the support of external audits.
Provide compliance guidance per defined quality system requirements to ensure efficient and effective completion of assigned CAPA’s, audit responses and quality notifications.
Ensure product compliance by performing product inspections, device history reviews, and product release authorization.
Provide support to identified improvement projects and initiatives.
This is a small international quality team located in Cleveland, Ohio and Best, The Netherlands. As part of this organization, you are empowered to use your voice and expertise to have a positive impact on your team, our business, and health technologies that will improve the health, well-being and care for people around world.
This position will be reporting to the Head of Refurbished Systems Q&R with a functional reporting line to the Senior Manager Q&R of Refurbished Systems Cleveland.
Location : Cleveland, Ohio
We are looking for:
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.
Knowledge and Experience:
Typically requires a Bachelor’s degree and 5 years of related experience
Working knowledge of appropriate global regulations (FDA), and standards (ISO13485)
3+ years of related experience in a regulated environment
Proficient in area of specialization in Quality Assurance
Ability to contribute in disciplines such as; CAPA’s, audits, system release and inspection, creating quality processes for compliance purposes and document reviews
Good analytical skills and experience in problem solving
Excellent communication skills (verbal and written)
Good working knowledge of various software packages including web based applications
This role comes with a competitive compensation and a generous holiday / vacation offering, but that’s not all. Quality is right on the top of Philips leadership agenda and that means you have the unique opportunity to come in and have a recognized voice to drive and witness exciting, transformational changes. You will be empowered to drive high quality, ground breaking innovations with a globally recognized, premium brand behind you. And when you are successful in this role’s mission, you will have an array of diverse career options open to you – across different functional areas, product lines, business groups and/or geographies. That is a commitment Philips Quality Leadership team has made and stands by.
Call to Action:
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.