Compliance Quality Engineer I

Philips; Varginha; Presencial; BRL 90 000 - 130 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Health insurance

Resumo da oferta

Philips is seeking a Compliance Quality Engineer I to join the Quality Enterprise Services team. You will lead analysis of defects, manage NCs, and drive CAPA within FDA-regulated ISO 13485 medical device settings.

This role emphasizes continuous improvement within the QMS, collaboration across functions, and ensuring regulatory compliance through improvement initiatives.

Qualificações

• 3+ years’ experience in FDA regulated (ISO 13485) medical device quality operations/manufacturing environments, with a focus on quality.
• Experience with CAPA processes, non-conformances, including problem identification, root cause analysis, implementation of solutions to prevent recurrence and drive continuous improvement.
• Bachelor’s degree in Engineering, Science, or related field (Master’s or higher is a plus).
• Strong analytical skills, attention to detail, and ability to work in a fast-paced, cross-functional environment.
• Proactive, results-driven, and committed to maintaining high standards of quality and compliance.

Responsabilidades

• Lead analysis of defects to determine dispositions of non-conformances and manage NCs.
• Facilitate effective CAPA.
• Support continuous improvement within the QMS.
• Propose and implement enhancements to processes, tools, and systems.
• Build strong relationships with internal and external partners.
• Drive overall quality performance and operational excellence.
• Ensure regulatory compliance through improvement initiatives.

Conhecimentos

CAPA processes

Root cause analysis

Non-conformances handling

Analytical skills

Cross-functional collaboration

Quality systems (QMS)

Formação académica

Bachelor’s degree in Engineering or Science

Descrição da oferta de emprego

Job Title

Compliance Quality Engineer I

Job Description

Compliance Quality Engineer I The Compliance Quality Engineering Team of the Quality Enterprise Services organization manages 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.
• Build strong relationships with internal and external partners.
• Drive overall quality performance and operational excellence.
• Ensure regulatory compliance through improvement initiatives.

You’re the right fit if:

• You have a minimum of 3+ years’ experience in FDA regulated (ISO 13485) medical device quality operations/manufacturing environments, with a focus on quality.
• You have experience/knowledge in CAPA processes non-conformances, including problem identification, root cause analysis, implementation of solutions to prevent recurrence and drive continuous improvement.
• You have a Bachelor’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 about our business, discover our rich and exciting history and learn more about our purpose.

Learn more about our culture of impact with care.