In this role you will ensure that processes for specifying and executing field actions are adequate to ensure the expectations of all key stakeholders are met. You will monitors and coordinate the different sub-system feeders to this process such as complaint handling, engineering change orders, kit suppliers, regulatory submission and field deployment. Finally, you will prepare key documents such as Health Hazard Evaluation documents, Correction and Removal documents, product recall files and various internal reports. Ensures alignment between risk assessment and management.
You are responsible for
Ensuring that processes for specifying and executing field actions of medium complexity are adequate to ensure the expectations of all key stakeholders are met
Leading cross functional team to release on time, high quality and compliant field actions of high complexity
Managing recall responses, recall file documentation and recall file completion
Preparing key documents such as Health Hazard Evaluation documents, Correction and Removal documents, product recall files and various internal reports
Continuously tracking field actions and provide ongoing information to FCO team as required
Ensuring alignment between risk assessment and management documentations and documentation for field actions
Managing recall responses, recall file documentation, recall file completion
Providing relevant feedback and insights from customers/filed to development/engineering teams to ensure learnings from previous projects are captured, synthesized and made available for next project teams
Continuously tracking field actions and providing ongoing information to Regulatory Operations as required
To succeed in this role, you should have the following skills and experience
3+ years experience in a medical device and/or other regulated industry (Pharma, IVD).
3+ years of working knowledge of appropriate global medical device regulations, requirements, and standards such as ISO 13485 and ISO9001, and FDA QSR.
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/philips-recruitment-process.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.