Quality Systems Engineer
Job TitleQuality Systems Engineer
The End-to-End (E2E) Quality System Process Expert supports development, deployment and maintenance of the Quality Management System within Philips Healthcare, ensuring Philips cross sector harmonization, standardization and regulatory compliance.
You will ensure process compliance to regulations, and that optimization and efficiency are built into the Business Management and Quality Management System processes across all sectors and groups in partnership with the other business functions.
Working in the medical industry brings much fulfillment, as well as unique challenges. As part of our HealthTech – focused company, you will be responsible for providing compliance and Quality Management System process improvement support to the End-to-End (E2E) Program teams to ensure compliance with optimization and efficiency in E2E processes.
Key areas of responsibilities (KARS) for this role include:
- Participates directly as the Quality Management System Expert in E2E deployment programs, in the Idea 2 Market, Market 2 Order, Order 2 Cash and applicable Enabling process arenas.
- Ensures compliance requirements and controls are embedded in applicable processes.
- Supports setup and deployment of the Quality Management Systems along business model lines as identified by End to End teams.
- Creates a solid network with E2E Program and Project teams, ARIS process modeling teams, Business Management System and Quality Management System owners, as well as any other stakeholders to support objectives.
- Formulates solutions across multiple disciplines to effectively achieve goals.
Quality Assurance is an integral aspect of the global Philips business including device design, development, manufacture, distribution, worldwide device marketing, sales, service, and post-market surveillance. This position is intimately involved in the process of ensuring Quality System Regulations are embedded within business processes and supports the harmonization of identified key processes by which the company and its sectors operate.
Location: Andover, MA
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.
Specific skill requirements for this role include:
- Bachelor’s degree, preferably in a scientific discipline
- Minimum of 7 years of experience working in Quality Assurance / Quality Engineering / Quality Systems supporting multiple functional disciplines within a global medical device industry.
- Proven experience in Quality Management System processes, including cross sector or business process standardization, ensuring effectiveness and efficiency while maintaining compliance with worldwide regulations
- A comprehensive understanding of the diverse worldwide medical device quality regulations, including areas of device design, development, manufacture, distribution, worldwide device marketing, sales, service, complaint handling and post-market surveillance
- An ability to successfully communicate and educate Quality Management System regulations, policies and strategies to teams at all levels of the organization
- Experience with deployment of Quality Management System processes as identified
- This position requires, an extensive knowledge of FDA QSR’s, ISO 13485, JPAL, China GMP’s and other worldwide Quality System Regulations.
This role comes with a competitive compensation offering 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.
Find our more information 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.
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