PQV Combination Product Analyst IV

Johnson & Johnson

. Handle high-volume end-to-end product quality complaint activities and adverse events .

Posted 9/30/2026full-timeSchaffhausen • SwitzerlandMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Quality Assurance and Quality Control within highly regulated environments, with a strong focus on Medical Device Reporting, complaint handling, and regulatory compliance. Proficient in risk assessment, process mapping, and leading change initiatives while ensuring adherence to industry standards.

Highest-signal resume keywords

Quality AssuranceMedical Device ReportingRegulatory ComplianceRisk AssessmentProcess Mapping

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Complaint HandlingRoot Cause AnalysisTrend AnalysisDefect CodingStatistical Process ControlCAPA DocumentationRegulatory ReportingData AnalysisInvestigation TechniquesProcess Improvement

Soft Skills

Strong Organization SkillsProject ManagementRelationship BuildingLeadershipCollaboration

Tools & Technologies

Process Excellence ToolsQuality Management SystemsStatistical Analysis SoftwareDocument Management SystemsRegulatory Compliance Software

Certifications & Qualifications

Biomedical Engineer LicenseRegistered Nurse LicensePhysician Assistant Certification

Industry Keywords

21 CFR Parts 4, 820, 803, 806, 210, 211, 314ICH Q10GMPGDPISO 13485:2003ISO 14971:2007/2012MEDEV 2.12CMDRMedical Device Directive 93/42/EECPharmaceutical Industry

About the role

Key responsibilities & impact

Handle high-volume end-to-end product quality complaint activities and adverse events
Perform Medical Device Reporting (MDR) assessments and document reportable/non-reportable regulatory decisions
Intake, triage, review, investigate, prioritize, and close complaints
Determine MDR reportability, recover field samples, conduct due diligence, perform trend analysis, defect coding, risk criticality assessment, and ensure holistic investigations
Evaluate QTL and ULC exceedances, determine investigation requirements, and assign investigations to applicable sites
Provide governance and oversight of complaint throughput, prioritization, MDR decisions, and KPI performance
Monitor complaints for new malfunction events requiring inclusion in malfunction description lists
Serve as PQV point person for post-market and complaint-handling regulatory/MDR questions
Provide guidance to subordinate Analyst roles and other PQV functions
Assess technical information, risks, investigations, and MDRs according to procedures, standards, and regulations
Provide backup PQVIS investigation support during increased complaint volumes
Collaborate with Global Medical Safety, manufacturing sites, LOC/BQ, and cross-functional stakeholders
Provide technical and product feedback for issue escalation, product enhancements, and future development
Ensure timely and uniform complaint records and regulatory reporting
Compile and analyze complaint-handling data, metrics, and trends
Support internal and external audits and inspections as a subject-matter expert
Interact with regulatory authorities, J&J operating companies, and global councils on quality-system regulatory trends
Provide product workflow leadership to PQV peers
Oversee PQC complaint monitoring and analyze monitoring outcomes
Lead root-cause identification and corrective-action coordination for compliance risk events, including CAPA/QI documentation
Lead process mapping and changes for SOPs, job aids, and work instructions
Drive process improvements using Process Excellence tools and lead or participate in special projects
Execute statistical and data-driven processes for controlled risk management and decision-making
Lead remediation activities and prepare protocols, results documentation, and report approvals
Develop and deliver training on processes, complaint handling, and regulatory reporting
Facilitate and collaborate with PQV Reporting and Surveillance on New Product Introduction processes
Interact with IT partners and application vendors as required

Requirements

What you’ll need

5+ years of related experience in Quality Assurance and/or Quality Control, preferably in pharmaceutical, medical device, or another highly regulated industry
Knowledge of the medical safety environment and regulations
Strong organization skills and ability to prioritize and manage workload
Strong knowledge of analytical, process mapping, investigation root cause, and risk assessment tools
Global mindset and demonstrated ability to lead change initiatives, manage projects, and develop strong relationships
Working knowledge and experience with 21 CFR Parts 4, 820, 803, 806, 210, 211, and 314
Working knowledge and experience with ICH Q10, GDP, GMP, GVP, ISO 13485:2003, ISO 14971:2007/2012, MEDEV 2.12, CMDR, and Medical Device Directive 93/42/EEC
Bachelor's degree in a technical, scientific, or engineering discipline required
Biomedical Engineer, Registered Nurse, Physician Assistant, or similar healthcare provider/science license/certification/degree preferred
Role located in EMEA
Ability to travel 5-10% domestically and internationally

Benefits

Comp & perks

Inclusive work environment
Diversity and dignity of employees
5-10% domestic and international travel opportunity