QMS & CAPA Engineer

Job Title
QMS & CAPA Engineer

Job Description

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
  
  

• 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
  
  

• Learn more about our business.
• Discover our rich and exciting history.
• Learn more about our purpose.