In this role, you have the opportunity to
You are the main interface between the QA team and development team. You facilitate meeting project goals in a compliant manner and you understand how quality policies and development 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.
Mentor and coach a growing development team on compliance requirements.
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.
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
Contribute and support to track quality objectives
You are a part of
This position will be part of the Quality team for Philips’ Imaging Components and Disease Management businesses. Philips Disease Management designs, develops and commercializes a range of software and hardware products as well as sterile disposable products. Philips Imaging Components designs, develops, and commercializes RF Receive Chain products at the Gainesville FL location.
To succeed in this role, you should have the following skills and experience
Bachelor/Master degree with at least 5 years relevant experience in Quality Assurance
Background in a Regulated Industry, Medical Devices or IVD, is required
Demonstrated experience in setting up and maintaining compliant Quality Management Systems is required
Experience with design controls in both Software and Hardware Development environment is required.
High degree of technical knowledge and experience in non-invasive neurodiagnostic products is a strong preference
Experience in supporting Notified Body and Regulatory Audit is a strong preference.
Experience with manufacturing quality control is a plus.
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
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).Describe in two to three lines what tangible and intangible benefits the incumbent will gain in this role.
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.
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 .
It is the policy of Philips to provide equal employment and advancement opportunities to all colleagues and applicants for employment without regard 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.