Medical Device Corrective Action Specialist

4 weken geleden

Best, Noord-Brabant, Nederland Philips Voltijd

Job Title:

Principal Correction and Removal Specialist

Job Description:

Program Manager, Correction and Removals

In this role, you will have the opportunity to contribute to the future of healthcare technology by ensuring the successful management of the Correction and Removal (C&R) process. You will lead end-to-end (E2E) field actions, collaborating with cross-functional teams to deliver solutions that meet both regulatory requirements and customer needs.

Your role:

  • Oversee the complete correction and removal process to ensure effective, compliant, and timely field action execution.
  • Work closely with cross-functional teams including complaint handling, investigation committees, engineering, regulatory bodies, and field deployment to coordinate activities.
  • Lead the coordination of recall responses, documentation, and regulatory submissions, ensuring compliance and alignment with risk assessments.
  • Collaborate with key stakeholders, including medical and quality leaders, to ensure the quality and effectiveness of all field actions and the continuous improvement of internal processes.
  • Provide valuable feedback from the field to engineering and development teams to enhance product quality and reduce future corrective actions.

You're the right fit if:

  • You have acquired 5-7 years of broad experience in Quality Management and/or Post Market Surveillance experience. You also have experience supporting post-market risk assessments, recall decisions and execution supporting audits, and proven ability to work independently.
  • Your skills include experience collaborating with local stakeholders for the proper adaptation of quality system processes and driving common Quality & Regulatory goals and objectives towards improved customer experience, patient safety and quality, operational excellence & dedicated regulatory compliance.
  • You have an in-depth knowledge of relevant medical device industry standards ISO 13485. Experienced with Corrective and Preventive Actions (CAPAs) and Recalls in a medical device setting. Bachelor's degree in a relevant scientific or engineering field or higher is preferred; Project Management experience is also preferred. Will consider candidates with equivalent relevant experience and education.
  • You have an ability to influence without expressed authority, have a strong accountability for results achieved, and a strong passion for patient safety & quality.
  • The ideal candidate will be viewed as an expert in Post Market Corrections and Removals as well as expertise in Project Management. A broad background in the Quality Management field as it pertains to the medical device industry.

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.

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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 commitment to diversity and inclusion .

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