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

Dice is the leading career destination for tech experts at every stage of their careers. Our client, SR Partners LLC, is seeking the following. Apply via Dice today!Job Title: Quality & Regulatory / Post-Market SurveillanceLocation: Boston, MA & Bothell, WA- HybridMode 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-conformancesEvaluate patient/user risk and determine severity and likelihoodRecommend actions such as Field Safety Corrective Actions (FSCA), recalls, or advisoriesSupport regulatory reporting decisions (FDA, EU MDR)Risk Management: Conduct and update risk assessments per ISO 14971Maintain and update:Risk Management Files (RMF)Hazard Analysis, FMEA, Fault Tree AnalysisEnsure risk controls are implemented and residual risks are acceptableCAPA Support:Partner with CAPA teams on root cause investigations and corrective actionsIntegrate risk evaluation into CAPA lifecyclePerform effectiveness checks and risk reassessment post-implementationRegulatory & Compliance: Ensure alignment with:FDA 21 CFR Part 820EU MDRISO 13485Support audits, inspections, and regulatory submissionsCross-Functional Collaboration: Work closely with:R&D / EngineeringQuality & Regulatory AffairsClinical and Field teamsProvide risk-based input for product changes and issue resolutionDocumentation:Prepare HHE reports, risk assessments, and CAPA documentationEnsure traceability across complaints, CAPA, and risk filesMaintain audit-ready recordsRequired Qualifications: Bachelor's or Master's degree in Biomedical Engineering, Electronics, or related field5 15 years of experience in:Medical device risk management & CAPAHHE / product safety evaluationStrong knowledge of:ISO 14971, ISO 13485FDA and EU MDR regulationsExperience with diagnostic imaging systems (Ultrasound preferred)Key Skills:Strong analytical and problem-solving skillsAbility to assess clinical and technical risksExcellent documentation and communication skillsStakeholder management across global teamsPreferred / Good to Have:Experience with Philips or similar medical device organizationsFamiliarity with post-market surveillance systemsSix Sigma / Quality certificationsUnderstanding of ultrasound imaging technologyPSRTEK is a reputed technology recruitment and IT staffing brand with a global footprint and an admired client base. As an ideas and innovation powerhouse with a culture of excellence, we bring remarkable expertise and deliver powerfully transformative results.