Compliance Quality Engineer I

Philips International; Barueri; Híbrido; BRL 120 000 - 180 000; Tempo integral

Resumo da oferta

Philips is seeking a Compliance Quality Engineer I to lead defect analysis, disposition of non-conformances, and CAPA activities within a fast-paced, ISO 13485 regulated environment. You will drive improvements across processes and tools, collaborating with internal and external partners to ensure patient safety and regulatory compliance.

The role emphasizes analytical rigor, attention to detail, and proactive problem-solving in a cross-functional setup in the São Paulo area.

Qualificações

• 3+ years’ experience in FDA-regulated medical device quality operations/manufacturing environments (ISO 13485).
• Experience with CAPA and non-conformances including root cause analysis.
• Bachelor’s degree in Engineering, Science or related field; Master’s or higher is a plus.

Responsabilidades

• Lead analysis of defects to determine dispositions of non-conformances and manage NCs.
• Facilitate effective CAPA activities and corrective actions.
• 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 regulatory compliance.

Conhecimentos

CAPA processes

Root cause analysis

Quality assurance

Analytical skills

Formação académica

Bachelor's degree in Engineering/Science or related field

Master's degree or higher (nice to have)

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. You may still be the right candidate for this or other opportunities at Philips. Learn more about our culture of impact with care. At Philips, we believe that every human matters. As a global health-tech leader, we focus on improving people’s health and wellbeing through meaningful innovation. The people who work here share our passion and are motivated to bring this purpose to life. For more than 130 years, we have been creating technologies and innovations that improve people's lives and support healthcare practitioners. Headquartered in the Netherlands and operating in more than 100 countries globally, we focus our advanced technology and deep clinical and consumer insights on Precision Diagnosis, Image Guided Therapy, Enterprise Informatics, Monitoring/ Connected Care, Sleep & Respiratory Care and Personal Health. Together, we deliver better care for more people because we believe that every human matters. That's why we're taking steps to create an environment where we acknowledge and embrace our differences and uniqueness and listen to and value each other's views. When people feel cared for and listened to, they bring their best qualities to work, leading to better collaboration, communication, innovation and success.

It is the policy of Philips to provide equal employment and advancement opportunities to all qualified employees and applicants for employment without regard to race, color, religion, sex, pregnancy/childbirth or related medical conditions, age, ethnic or national origin, sexual orientation, gender identity or expression, physical or mental disability, genetic information, citizenship status, veteran or military status, marital or domestic partner status or any other characteristic protected by law. As an equal opportunity employer, Philips is committed to fostering a culture where all are treated with respect and professionalism. To ensure reasonable accommodations for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veterans' Readjustment Act of 1974 and Title I of the Americans with Disabilities Act of 1990, applicants that require accommodation in the job application process may contact 888-367-7223, option 5, for assistance. Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug-free workplace. Know Your Rights