Philips Quality Manager, Senior in Eugene, Oregon
In this role, you have the opportunity to:
We are looking for a change leader to align quality practices developing medical device business to the Philips QA standards. The challenge is to integrate a fast growing business in a corporate structure, while enabling market launches and growth. For this you will need excellent influencing skills, in-depth knowledge of relevant Quality Assurance practices, a working knowledge of the regulatory context and understanding of design controls in a SW development environment.
You are the main interface between the QA team and business management. You facilitate meeting business goals in a compliant manner and you understand how quality policies and business processes interact. You work closely with Regulatory Affairs, Product Development, Clinical, Operations, Service, Supply Chain and Marketing & Sales.
You are responsible for:
Support integration of a recently acquired medical device business in the Philips organization.
Manage Q-improvement and integration plans.
Manage and coach a growing QA/ QC team.
Collaborate with other functions and departments on QA related aspects.
Ensure released products are developed, manufactured, distributed and serviced at the right quality levels, in compliance with relevant regulations and Philips policies.
Ensure Quality & Regulatory aspects are adequately covered in the selection, control and monitoring of suppliers.
Responsible to ensure the adequate release of incoming material, intermediate materials.
Release of finished devices for clinical tests and delivery to customers.
Be an ‘ambassador’ for quality assurance and drive quality awareness and improvement.
Compliance, effectiveness and efficiency of the QMS and operations.
Collaborate with Business and Q&R Management to establish strategic plans and objectives
Establish and track quality objectives
You are a part of:
This position will lead the newly developing Quality team for Philips’ newest acquisition, Electrical Geodesics, Inc. (EGI). EGI is a medical device company that designs, develops and commercializes a range of non-invasive neurodiagnostic products used to monitor and interpret brain activity. A key component of these products is EGI’s proprietary dense array electroencephalography (dEEG) platform technology. The dense array method gathers brain activity data from many more electrodes than conventional EEG products (up to 256), generating significantly higher quality and more precise levels of information. With regulatory clearance in the US, EU and a number of other major international regulatory bodies, the Company’s technology has been increasingly adopted as a powerful research tool and more recently as a cost effective and patient friendly clinical neurodiagnostic platform.
To succeed in this role, you should have the following skills and experience:
You are a hands-on leader, leading by example, coaching and teaching the Quality team.
You are responsible for compliance of the Quality Mgmt. System (QMS) with relevant standards and regulations.
Bachelor/Master degree with at least 7 years relevant experience in Quality Assurance
Background in a Regulated Industry, Medical Devices, IVD or Pharma, is required
Demonstrated experience in setting up and maintaining compliant Quality Management Systems is required
Experience with design controls in Software Development environment is required.
Experience with manufacturing quality control is a strong preference.
Proven track record as a change leader is a strong preference.
Practical knowledge of medical European and US standards and regulations is a strong preference
Proven track record in integration of corporate quality systems is a plus.
Excellent verbal and written communication skills (English)
Strong communication and influencing skills
In return, we offer you:
The opportunity to work in an emerging business group and lead a newly developing clinical team. This position will sit at the forefront of cutting edge technology and lead the team to future success. You will help to create and shape the culture and develop the future team.
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. 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 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.
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.