Philips Quality Manager, Menlo Park in Menlo Park, California
Manage the Quality System at the Menlo Park facility including Operational Quality, Compliance, and Design Quality Assurance. Responsibilities include Quality Management Controls including Management Review and Quality Audits, Production and Process Controls and Design Controls. See Job Family Description for Q&R Management (SVAL).
Quality Manager (Menlo Park)
In this role, you have the opportunity to
As the incumbent of 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.
Drive Quality activities on the various product lines at IGT Devices, to include: participation on development teams, , working with the manufacturing lines to initiate quality receiving and calibration improvements, assist in performing internal audits, and perform follow-up activities on NCR’s and CAPA’s. Support activities will be carried-out in accordance with industry and regulatory standards and Company Procedures and Policies.
You are responsible for
To formulate and implement the Business' long-range quality, regulatory, and compliance policy.
Create Q&R awareness level as determined within the organization.
Enforces quality systems and harmonizes them across the Business sites and Sector; establish an effective Management Review process, including routine reporting.
Introduce and implement the quality processes and tools required to ensure product quality and customer satisfaction.
Manages compliance to FDA regulations and other Regulatory Agencies as required, guidelines and policies to all products and operations are consistent with those regulations.
Manages the review and approval of finished products manufactured for and by the company in accordance with their approved specifications. Includes Complaint handling.
Manages all inspections and questions relating to the operation of the manufacturing sites in coordination with all other applicable company groups.
Manages product recall activities to include recall policies and procedures for the company. Additionally, manage product complaint activities and processes.
Direct the Audit Program for the organization.
You are a part of
A Quality group dedicated to maintaining high standards on medical device products used to improve the quality of human life throughout the world.
To succeed in this role, you should have the following skills and experience
4+ years experience in a medical device setting preferred.
Experience integrating quality systems.
Experience in a manufacturing setting strongly preferred.
Strategic thinker, quality oriented.
Effective communication skills/relationship builder.
In return, we offer you
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.
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.