Quality Engineer

Job description

Job Title

Quality Engineer

Job Description

Your challenge

In this Quality & Regulatory (Q&R) role within Philips, 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.

In Hospital 2 Home, (H2H) your challenge is to work with post market data and communicate the findings to the software development teams and with 3rd party software suppliers, to timely develop products complying with all applicable standards.

The software teams you work with are in 2 locations, Baltimore and Bangalore..

Responsibilities

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 successfully dealing with and managing Philips relationships with approval agencies such as the US Federal Drug Administration (FDA).

Key areas of responsibilities (KARS) for this role include:

·  Ambassador of the Quality processes,
·  Ensure the right implementation of the Quality processes in the software teams, Support Quality System related activities for the H2H BU
·  Ensure and maintain compliance towards the different medical standards and legislation (FDA, MDD, ISO13485, IEC 60601 etc.)
·  Facilitate and maintain Safety and fail mode product analyses,
·  Partner with suppliers and development teams to proactively engineer quality and compliance into the products, Partner with Procurement and SQA in Supplier Qualification process
·  As appropriate lead CAPA activities for assigned CAPAs

Your team

As a result of Philips renewed commitment to Quality, it has recently restructured its organization to ensure you and your department have clear interfaces with Philips Business Group and Market leadership, and can harness the expertise of five Centers of Excellence (COEs). These 5 COEs specialize in the following capabilities: Regulatory & Clinical Affairs, Supplier Quality, Quality Management System, Quality Assurance & Engineering, and Compliance & Audit. As part of this new structure, 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.

As Quality Engineer you are part of the H2H Business Unit, in a world of digital health. In this new role you are focusing on supporting new product introduction and supporting current distributed product operation's needs (supporting service installation and product release post design transfer) in Baltimore In this exciting role you are close connected to the Device SQE's for H2H products.

Your skills around software development for medical devices is well established together with your ability to guide and coach the organization around you. You are a networker, understand the current requirements around Security and Privacy and are self-propelling in this.

Location : Baltimore

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:

·  Work experience with IEC 62304
·  Medical device background preferred
·  Technical background
·  Experience with supplier management
·  Understanding of APQP is a pre
·  ISO 13485, EN 60601
·  Safe Agile work experience
·  3 plus years' experience in Q&R, regulated environment preferred

Our offer
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.

Apply to Job ID 232919

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

Contact

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