In this role, you have the opportunity to
Oversee and provide direction for the IC Sites post market surveillance systems. Establish strategic direction. Develop long-term strategies to meet Global and Site goals. Coordinate a broad, multi-disciplined work unit. Accountable for achievement of compliance, financial, and performance goals. Responsible for establishing, monitoring, and maintaining the quality post market surveillance systems.
You are responsible for
Writes and maintains Quality Post Market Surveillance Procedures, to include Work Instructions and SOP updates
Implements, maintains, and/or improves the quality system to meet or exceed regulatory and ISO compliance for Post Market Surveillance.
Maintains current knowledge of cGMP/QSR, ISO, and other related regulations and conducts training as appropriate
Ensure the Quality functional requirements are compliant with corporate procedures as well as industry standards and regulations
Manage, facilitate, and support Customer Complaint activities
Manage, facilitate, and support FCO activities
Propose, implement and enforce quality improvements
Manage a staff of personnel, which may include Supervisors, Engineers, Specialists and Coordinators
To succeed in this role, you should have the following skills and experience
A Bachelor's Degree, preferably in a technical discipline, is required in order to enable understanding of the quality and business aspects of the IC Sites.
Experience with external audit agencies. Experience in development of post market surveillance systems procedures.
At least 5 years’ experience in engineering, operations, or quality, with at least 2 years of direct supervisory/management experience.
Attention to detail and accuracy, good organizational and planning skills
Demonstrated ability to meet deadlines
Solid oral and written communication skills
5 years working in Medical Devices preferred
3+ years of experience in Post Market Surveillance management preferred
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.