In this role, you have the opportunity to
Drive and support CT/AMI Site Haifa compliance to international medical device regulations, ISO13485, Philips and general quality system requirements through audit planning, control of timely resolution of audit findings as well as the reporting of finding status to the site Haifa management, supporting preparations of external audits and the implementation of the Business’ long-range quality, regulatory and compliance policy.
You are responsible for
Development, implementation, and maintenance of a compliant CT/AMI Quality Audit program in accordance to the established quality management system
Process owner for the CT/AMI Site Haifa Audit Management process
Definition and specification of the annual audit schedule and the communication of such into the organization
Establishment of audit checklists in accordance to the QMS processes and or products
Support of the execution of external audits, internal audits and inspections including FDA, Notified Body and other 3rd party audits in PMSTL CT/AMI.
Interaction with cross functional peers to implement the audit plan, including supervision of the internal quality auditors.
Execution of internal quality audits
Review of compliant documentation of audit findings and audit reports, including correct findings classification
Tracking and monitoring of audit finding action plans until closure, including assistance in the resolution to closure.
Track and monitor key performance indicators (KPIs) and implement corrective actions as required.
Reporting of the audit KPIs to the Q&R data analyst
Provision of class room trainings in ‘How to behave during an Audit’
Maintains overview of the qualification (including refresher trainings) of internal auditors
You are a part of
Q&R organization supporting CT/AMI Site Haifa compliance.
To succeed in this role, you should have the following skills and experience
Bachelor of Science or equivalent in technical/ engineering or clinical field
At least 4 years professional work experience with medical device regulations and standards (such as US FDA QSR, EU MDD, Canadian CMDCAS, Japan PAL regulation and other WW regulations and standards)
Certified ISO 13485 auditor – an advantage
Experience and knowledge in production activities and production floors of medical / pharmaceutical firms
Fluent verbal and written English
Good communication skills and convinced team player
Attention to detail and self-directed
In return, we offer you
Endless opportunities to learn and develop your career in the directions to which you aspire. Philips Healthcare is a place where you will work with others whose far-reaching ideas and accomplishments have impacted over 200 million lives already
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 .