Department Description:
Philips Healthcare has established an Industrial Campus for imaging systems in Suzhou Industrial Park. With a total investment of USD 54 million committed to its development in the next five years, exhibiting the commitment of Philips to global health and well-being, Healthcare Suzhou aims to build up a center of excellence of Sourcing, Manufacturing and R&D. It will also be dedicated to be the voice of emerging markets.
The site covers entire imaging portfolio, including MR, CT, NM, DXR, IXR, and Ultrasound. The focus will be product development for the emerging markets, tailored product designing for local customers, as well as sourcing and manufacturing for the global market.
If you are competent, confident, creative and humble, if you’d like to learn the most advanced knowledge of Imaging System, if you want to broaden your global mindset by working closely with a diversified team in a global environment, if you are passionate and want to realize your dreams in a growth-oriented company, please join us! You will find Healthcare Suzhou a great place to work and develop yourself!
Your Responsibilities:
Develop the roadmap of continuous improvement opportunities that can be operational in the product development environment;
- Develops, promotes and communicates the Quality Policy and Quality Strategy throughout R&D;A member R&D Leadership Team on regulatory strategies, potential areas of concern and new regulatory developments;Directs R&D global resources to ensure the effective and efficient use of department resources and continuous process harmonization and improvement at each site. Provides ongoing guidance, training and development to the staff;
- Reviews, approves and ensures the implementation of R&D-wide policies and procedures at each site. Drives continuous improvement of the implemented Quality System. Ensure the R&D teams are in full compliance with all applicable requirements;
- Provides strategic development and support of the BU’s global product submission strategy to ensure that global business objectives are fully met;
- Maintains strong relationships with regulatory agencies, competent authorities and standards organizations which impact the business. Represents the R&D function at all external audits and inspections including FDA, BSI (Notified Body) and all other third-party audits;
- Ensures the R&D function is in alignment and adopts all PH and Imaging Systems Q&R initiatives;
- Represents the R&D function at industry and standards development meetings, as appropriate.
Your Profile:
- Minimum Bachelor of Science degree (B.S.) in biological sciences, engineering or equivalent;
- Medical degree and clinical working experience is preferred;
- Ten (10) plus years of progressive experience in managing design quality and/or regulatory function within an R&D organization in the medical device industry;
- Successful track record of obtaining global product approvals in the medical device industry;
- Successful track record with U.S. FDA inspections and Notified Body assessments;
- Expert understanding of global Quality System requirements as they apply to the medical device industry;
- Demonstrated ability to lead and influence teams and individuals.
Do you fit this profile? Then we might have the job for you! Our high-tech campus, new clean-rooms, advanced infrastructure and most of all our teams of world-class R&D professionals are available for you to make your and our dreams come true.
Philips Career Center job number 015746, please apply directly to job at www.philips.com/career AND/OR submit your resume along with the cover letter to jeremy.gao@philips.com identifying the job portal you see our job advertisement.