Compliance Quality Engineer

Compliance Quality Engineer

The role is focused on ensuring the Nonconformance and CAPA subsystems are in control, and that actual or potential non-conformities are addressed.

Your role:

• Driving and/or owning corrective and preventive actions.

  
  

• Leading cross-functional problem-solving sessions to address significant QMS issues, utilizing structured methodologies like root cause analysis and driving the implementation of solutions.

  
  

• Working cross-functionally with global stakeholders to ensure timely resolution of all CAPAs.

  
  

• Reporting to senior management on status of CAPAs.

  
  

• Being ambassador of the Philips quality policy within the organization.

  
  

• Monitoring, identifying, escalating and potentially leading Quality improvement efficiency initiatives in commercial operations

  
  

• Participating in continuous improvement initiatives within the QMS, proposing and implementing enhancements to processes, tools, and systems to drive overall quality performance and operational excellence.

  
  

• Taking ownership of basic processes in the assigned area/areas to ensure that QMS is efficient and meets the regulatory requirements.

  
  

• You have a Bachelor's / Master's Degree in Mechanical Engineering, Industrial Engineering, Science or equivalent.

  
  

• You have previous CAPA experience in highly regulated environments/industries such as medical devices, Pharma, Automotive.

  
  

• You have minimum 3 years of experience in managing product and/or process risk assessments per ISO 14971

  
  

• You have led quality improvement projects on cost of non/poor quality

  
  

• You have a proactive and entrepreneurial mindset, and act fast on potential issues.

  
  

• You have extensive experience in working with commercial functions and service/installation functions within the organization.

  
  

• You are able to deal with stakeholders and teams based globally.

  
  

We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week.

About Philips
We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others.
• Learn more about our business.
• Discover our rich and exciting history.
• Learn more about our purpose.
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 culture of impact with care here.

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