Philips Director Quality in Eugene, Oregon
Quality leader shall integrate and transform all aspects of quality for medical and non medical devices comprised of hardware and software, and software only. Improve performance; integrate fast growing businesses in a corporate structure, enable market launches and rapid expansion. For this you will need state of the art quality systems, engineering, assurance, compliance and medical and non medical product quality domain knowledge. Exceptional leadership and influencing skills required.
In this role, you have the opportunity to: Be a strong Quality leader, integrate and transform all aspects of quality for medical and non medical devices comprised of hardware and software, and software only. Improve performance; integrate fast growing businesses in a corporate structure, enable market launches and rapid expansion. For this you will need state of the art quality systems, engineering, assurance, compliance and medical and non medical product quality domain knowledge. Exceptional leadership and influencing skills required.
You: Are the main interface between the Quality functions and business management. You facilitate meeting 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:
Lead QMS integration and improvement in a recently acquired medical device business in the Philips organization.
Manage budget and timeliness.
Manage and coach a growing Q team.
Ensure all medical and non medical products and services comply with all applicable regulations, standards, and policies.
Ensure Quality & Regulatory aspects are adequately covered in the selection, control and monitoring of suppliers.
Responsible for all aspects of quality throughout the entire product lifecycle.
Be an ‘ambassador’ for quality assurance and drive quality awareness and improvement.
Collaborate with Business and Q&R Management to establish strategic plans and objectives
Establish, track and report quality objectives throughout the entire enterprize
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.
Background in Medical Devices 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
Bachelor/Master degree with at least 7 years relevant experience in Quality Assurance
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).
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.