Quality Engineer – Product Quality Vigilance (12‑month contract)

About the role

The Quality Engineer will lead and support investigations of product quality complaints for Janssen commercial and clinical products. Working from Cork, you will act as the single point of contact for Product Quality Vigilance (PQV) across manufacturing sites, ensuring investigations are thorough, documented and aligned with regulatory requirements.

Key responsibilities

• Conduct holistic complaint investigations and document findings in the PQC database.
• Evaluate technical data to confirm appropriate analysis, failure mode identification and root‑cause determination before complaint closure.
• Serve as the PQV SPOC for manufacturing sites, raising awareness of aging, upcoming due dates and prioritisation.
• Coordinate failure investigations and support the preparation of Medical Device Reports.
• Manage corrective and preventive actions, ensuring timely escalation according to SOPs.
• Support regulatory and field‑action committees and assist during health‑authority inspections.
• Collaborate across departments and sites to provide product insights that improve design inputs and surveillance activities.
• Travel domestically and internationally up to 5‑10% as required.

Required profile

• Experience in complaint management, root‑cause analysis and CAPA processes within a regulated environment.
• Ability to work independently and as part of a global, cross‑functional team.
• Strong communication skills to convey investigation outcomes and process improvements.
• Willingness to travel occasionally for site visits and inspections.

Required skills

• Knowledge of complaint investigation methodologies.
• Familiarity with Medical Device Reporting procedures.
• Understanding of Corrective/Preventive Action (CAPA) processes.