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As the Quality Engineer leads complex complaint investigations and associated quality activities with minimal supervision. The role is responsible for advanced problem solving, data and trend analysis, protocol and report authorship, and driving root cause analysis to ensure regulatory compliance.
About The Role
Lead and manage complaint investigations and related quality activities with minimal supervision. Responsible for complex problem‑solving, data analysis, and ensuring compliance with regulatory standards. Acts as a subject–matter expert and drives continuous improvement.
Main Responsibilities
Lead complaint investigations and manage sample handling, reporting, and documentation.
Conduct or perform ad‑hoc investigations into product and equipment failures.
Author and review testing protocols and final reports.
Drive root cause analysis and corrective/preventive actions.
Identify and respond to potential product issues proactively.
Collaborate with cross‑functional teams including Sustaining Engineering and Product Development.
Support regulatory inspections and audits.
Analyze complaint data to identify trends and triggers.
Mentor junior engineers and contribute to process improvements.
About You
BS/MS in engineering, science, or related field.
2–4 years in a regulated environment, preferably in clinical investigations.
Strong understanding of quality systems and document control.
Advanced problem‑solving and analytical skills.
Excellent communication, presentation, and technical writing skills.
Experience in protocol/report writing and statistical analysis (e.g., Minitab, DOE).
Proven ability to lead projects and work independently.
Knowledge of ISO, FDA, OSHA, ASTM standards.
Strong organisational skills and attention to detail.
Supporting equipment validation activities and assisting with test method transfers to enable the successful launch and operation of the new laboratory.
Supporting lot release activities.
Location & Compensation
Primary Work Location: IRL BD and CO Dublin South. Additional Locations may apply.
Salary range: €43,300.00 – €66,025.00 EUR annual.
Equal Opportunity Employer
Becton, Dickinson and Company is an Equal Opportunity Employer. xcfaprz We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally–protected characteristics.
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Sprachkenntnisse
- English
Hinweis für Nutzer
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