Quality & Regulatory / Post-Market Surveillance

Responsibilities

• Perform HHE assessments for complaints, field issues, and non-conformances.
• Evaluate patient/user risk and determine severity and likelihood.
• Recommend actions such as Field Safety Corrective Actions (FSCA), recalls, or advisories.
• Support regulatory reporting decisions (FDA, EU MDR).
• Conduct and update risk assessments per ISO 14971.
• Maintain and update: Risk Management Files (RMF), Hazard Analysis, FMEA, Fault Tree Analysis.
• Ensure risk controls are implemented and residual risks are acceptable.
• Partner with CAPA teams on root cause investigations and corrective actions.
• Integrate risk evaluation into CAPA lifecycle.
• Perform effectiveness checks and risk reassessment post-implementation.
• Work closely with: R&D / Engineering, Quality & Regulatory Affairs, Clinical and Field teams.
• Provide risk-based input for product changes and issue resolution.
• Prepare HHE reports, risk assessments, and CAPA documentation.
• Maintain traceability across complaints, CAPA, and risk files.
• Maintain audit-ready records.

Requirements

• Bachelor's or Master's degree in Biomedical Engineering, Electronics, or related field.
• 5+ years of experience in: Medical device risk management & CAPA, HHE / product safety evaluation.
• Strong knowledge of: ISO 14971, ISO 13485, FDA and EU MDR regulations.
• Experience with diagnostic imaging systems (Ultrasound preferred).

Key Skills

• Strong analytical and problem-solving skills.
• Excellent documentation and communication skills.
• Stakeholder management across global teams.

Preferred / Good to Have

• Experience with Philips or similar medical device organizations.
• Familiarity with post-market surveillance systems.
• Six Sigma / Quality certifications.
• Understanding of ultrasound imaging technology.