Job Information
Philips QMS & CAPA Engineer in Haifa, Israel
As QMS Compliance Engineer you will be responsible for driving and supporting CT/AMI QMS compliance to international medical device regulations, ISO13485, Philips and general quality system requirements. Additionally, you will be responsible for managing and monitoring CAPA activities.
Your role:
Ensure readiness for External Audits
Support of the execution of external audits, internal audits and inspections including FDA, Notified Body and other 3rd party audits in CT/AMI
Execution of internal quality audits
Assists organizational units in addressing compliance deficiencies
Global facilitation of the CAPA process per all relevant procedures
Be the center of knowledge for all the CAPA practices and the Trackwise tool
Support and present CAPA during internal and external audits successfully
Provide other compliance support, including reviewing audit reports, including correct findings classification, and responses to audit findings for completeness and effectiveness and providing training on key compliance topics
Support tracking and monitoring of audit finding action plans until closure, including assistance in the resolution to closure
Support tracking and monitor key performance indicators (KPIs) and implement corrective actions as required
Perform analyses and continuous monitoring in support of internal audits, management reviews, and external audits
Supports the implementation of the Business’ long-range quality, regulatory and compliance policy. Supports managing plans for all QMS parts in scope while maintaining compliance and effectiveness throughout the duration of transitions
You're the right fit if you have:
Bachelor of Science or equivalent in technical/ engineering or clinical field
At least 3 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)
Fluent verbal and written English
Good communication skills and convinced team player
Attention to detail and self-directed
About Philips
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If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our commitment to diversity and inclusion here.
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