Compliance Quality Engineer II

Job Title

Job Description

Compliance Quality Engineer II
The Compliance Quality Engineering Team of the Quality Enterprise Services organizationmanages the quality engineering processes including quality nonconforming investigations, equipment calibration issues, out-of-tolerance cases, and investigations of other nonconformities to support compliance, continuous improvement, patient safety, quality, and maintain our license to operate. 

Your role:
 

• Lead analysis of defects to determine dispositions of non-conformances and manage NCs. 

• Facilitate effective Corrective and Preventive Actions (CAPA). 

• Support continuous improvement within the Quality Management System (QMS). 

• Propose and implement enhancements to processes, tools, and systems. 

• Discuss strategic quality metrics and reports with stakeholders. 

• Build strong relationships with internal and external partners. 

• Drive overall quality performance and operational excellence. 

• Ensure regulatory compliance through improvement initiatives. 

• Mentor less experienced engineers and lead cross-functional teams. 

You're the right fit if: (4 x bullets max)

• You have a minimum of5+ years’ experience in FDA regulated (ISO 13485) medical device quality operations/manufacturing environments, with a focus on quality. 

• You have detailed experience/knowledge in CAPA processes non-conformances, including problem identification, root cause analysis, implementation of solutions to prevent recurrence and drive continuous improvement. 

• Leading cross-functional teams. 

• You have aBachelor’s degree in Engineering,Science,or related field (Master's or higher is a plus).  

• This role requires strong analytical skills, attention to detail, and the ability to work in a fast-paced, cross-functional environment. Candidates must be proactive, results-driven, and committed to maintaining high standards of quality and compliance.

How we work together
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
Are you ready to do the work of your life to help the lives of others? Learn more aboutour business, discoverour rich and exciting history and learn more aboutour 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.

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