In this role, you have the opportunity to
Work within the Quality Management System (QMS) to support the Design Assurance process during the assessment and implementation of design changes to existing medical devices. Under the direction of Design Assurance Management, you will apply company policy and procedures to analyze situations or data and draw conclusions. Assignments will include creating, reviewing and updating documents, auditing Design History Files and actively participating as a core team member on design changes projects, Tasks on design change projects can include review of product requirements, risk management, detailed design, verification and validation activities and design transfer to production.
You are responsible for
Understand the processes and intent of all aspects of the QMS related to Design Controls.
Understand shelf life and biocompatibility testing to create and facilitate creation of associated test procedures and reports.
Facilitate updates to product risk analyses and risk management files.
Using engineering principles, analyze situations or data to identify gaps between project work product and the QMS
Work with sustaining teams and other Design Assurance QEs to assure compliance to the QMS.
Develop familiarity with our products and analyze complaint data, post market surveillance and risk analysis to assist in the identification of potential product improvements based on sound engineering principles.
Lead Corrective and Preventive Actions (CAPA) and QMS continuous improvement projects as they relate to Design Assurance.
Build stable relationships internally.
To succeed in this role, you should have the following skills and experience
US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa.
Requires a B.S. degree in Science, Engineering or Technology or associated fields.
Working knowledge of the new product design and development in a regulated environment; preferably medical device.
Working knowledge of the application of risk management; preferably to medical device development.
Excellent organizational and interpersonal skills working in a cross-functional teams.
Ability to organize and prioritize workflow across multiple projects in order to meet established time frames and schedules.
3+ years experience in Quality Assurance, including quality systems, standards, metrics, and tools
3+ years experience in medical device industry.
Working knowledge of medical device regulations (FDA 21CFR80.820, FDA 21 CRF Part 11, ISO13485, ISO10993, ISO14971, IEC60601, IEC62304).
Certified Quality Engineer (CQE) preferred.
Experience supporting internal and external audits.
Proficiency with the following software programs - Microsoft Excel, PowerPoint, and Word and Visio.
Experience working with PLM systems (e.g. Windchill), statistical software, defect tracking tools (e.g. ClearQuest), complaint management tools.
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 . Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways.
To find out more about what it’s like working for Philips at a personal level, visit the Working at Philips page on our career website, where you can read stories from our employee blog . Once there, you can also learn about our recruitment process , or find answers to some of the frequently asked questions .
It is the policy of Philips to provide equal employment and advancement opportunities to all colleagues and applicants for employment without to age, color, citizenship, disability or perceived disability, ethnicity, gender, gender identity or expression, genetic information, marital or domestic partner status, military or veteran status, national origin, pregnancy/childbirth, race, religion, sexual orientation, or any other category protected by federal, state and/or local laws. Philips is an equal employment opportunity and affirmative action employer Disability/Veteran.
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.