Opening for Quality & Regulatory / Post-Market Surveillance || Boston, MA & Bothell, WA-Hybrid

Job Title: Quality & Regulatory / Post-Market Surveillance

Location: Boston, MA & Bothell, WA- Hybrid

Mode of Hire: Contract

Job Description:

Role Summary:

We are seeking a skilled Risk & Health Hazard Evaluation (HHE) Specialist to support CAPA and post-market activities for ultrasound systems. This role is critical in ensuring patient safety, regulatory compliance, and effective risk management by evaluating field issues, complaints, and product non-conformances.

Key Responsibilities:

Health Hazard Evaluation (HHE):

• 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)

Risk Management:

• 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

CAPA Support:

• 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

Regulatory & Compliance:

• Ensure alignment with:
  • FDA 21 CFR Part 820
  • EU MDR
  • ISO 13485
• Support audits, inspections, and regulatory submissions

Cross-Functional Collaboration:

• Work closely with:
  • R&D / Engineering
  • Quality & Regulatory Affairs
  • Clinical and Field teams
• Provide risk-based input for product changes and issue resolution

Documentation:

• Prepare HHE reports, risk assessments, and CAPA documentation
• Ensure traceability across complaints, CAPA, and risk files
• Maintain audit-ready records

Required Qualifications:

• Bachelor's or Master's degree in Biomedical Engineering, Electronics, or related field
• 5 15 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
• Ability to assess clinical and technical risks
• 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