Location: N/A
Job Summary:
Job Duties and Scopes
- Support Quality Management System (QMS) activities for Philips Enterprise Informatics.
- Implement and direct Risk Management policy and processes.
- Ensure compliance with FDA regulations and product safety.
- Monitor product risk management performance and update deliverables.
- Perform quality engineering tasks and analyze market feedback.
- Participate in Corrective/Preventive Action (CAPA) programs and audits.
Required Skills
- Strong knowledge of medical device industry standards (ISO 13485, ISO 14971).
- Experience in quality systems, audits, and CAPAs.
- Ability to influence stakeholders without direct authority.
- Strong analytical and problem-solving skills.
Required Experiences
- 10+ years in Quality Management and Risk Management.
- Proven ability to lead audits and work independently.
- Bachelor's degree in a relevant scientific or engineering field preferred.
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