PQV Combination Product Analyst IV (MedTech)

Location: Beerse, Antwerp, Belgium; Ringaskiddy, Cork, Ireland; or Schaffhausen, Switzerland. The role is within EMEA and may require 5–10% domestic and international travel.

Base pay: €72,500–€115,230 annually, plus an annual bonus or sales commissions depending on pay grade and location.

Company

Johnson & Johnson MedTech develops healthcare technologies and solutions across the medical technology sector.

What you will do

• Manage high-volume, end-to-end product quality complaint handling, including intake, triage, investigation, closure, trend analysis, defect coding, and risk criticality assessment.
• Perform Medical Device Reporting evaluations and document the rationale for reportable and non-reportable regulatory decisions.
• Coordinate complaint governance, throughput, prioritization, KPI delivery, monitoring, and escalation of quality issues.
• Lead root-cause investigations, corrective actions, remediation activities, process mapping, and updates to SOPs, work instructions, and job aids.
• Collaborate with medical safety, manufacturing sites, local operating companies, quality teams, IT, vendors, and other stakeholders on complaint management and change initiatives.
• Support audits and regulatory inspections, provide subject-matter expertise, deliver training, and lead or participate in special projects.

Requirements

• 5+ years of related experience in Quality Assurance and/or Quality Control within pharmaceutical, medical device, or another highly regulated industry.
• Bachelor’s degree in a technical, scientific, or engineering discipline; a Master’s degree is preferred.
• Knowledge of the medical safety environment and applicable regulations, including MDR requirements.
• Strong skills in analytical methods, process mapping, root-cause investigation, risk assessment, project management, and change leadership.
• Working knowledge of applicable regulatory and quality standards, including 21 CFR, ICH Q10, GDP, GMP, GVP, ISO 13485, ISO 14971, MEDEV 2.12, CMDR, and the Medical Device Directive.
• Ability to work independently, prioritize workload, communicate with all management levels, and influence cross-functional stakeholders.

Nice to have

• Biomedical engineering, registered nursing, physician assistant, or a similar healthcare or science qualification.
• Experience with Quality Management Systems, ISO 9001, compliance management, continuous improvement, and fact-based decision-making.

Culture & Benefits

• Inclusive work environment focused on individual dignity, diversity, and merit.
• Annual bonus with a target determined by pay grade and location, or sales commissions where applicable.
• Vacation, parental leave of at least 12 weeks, bereavement leave, caregiver leave, and volunteer leave.
• Well-being reimbursement and financial, physical, and mental health programs.
• Recognition awards and access to insurance plans under applicable plan terms.