In this role, you have the opportunity to
We are looking for a strong leader to oversee quality operations of a new Philips facility for the Drug Coated and Specialty Balloon franchise within Philips Image Guided Therapy Devices. The challenge is to help facilitate the manufacturing transfer from the current facility, build up a new team to support production and quality control, and 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 combination product environment.
You are the main interface between the QA team and business management. In this role, you would be the management representative and quality system owner. 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
Building a talented team that will support production (e.g., quality engineering, QC, receiving inspection, analytical laboratory)
Support integration of a recently acquired medical device business in the Philips organization.
Manage quality improvement and integration plans.
Manage and coach the existing quality team (Design Assurance, document control, training)
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.
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
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 10 years relevant experience in Quality
Background in a Medical Devices, Pharma, or Combination Products is required
Demonstrated experience in maintaining compliant Quality Management Systems is required
Experience with design controls in combination products or med device/pharma environment is required.
Experience with manufacturing quality control and quality engineering
Practical knowledge of medical European and US standards and regulations
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 a growing business group and lead a newly developing quality 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 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 .
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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.