Product Quality Engineer with experience in product and process quality including new product introduction in an ISO 13485 and FDA 21 CFR Part 820 IVD manufacturing environment, required by join a leading manufacturing facility in Dublin. The quality function works cross-functionally with Engineering, Production and Procurement to cover a wide area of responsibilities such as CAPA, Non-Conformances, Risk Management, Deviations, Inspections and Regulatory audits, Complaint Handling, Validation and Product Release.
The Dublin site is currently involved in new product introductions, so this is an exciting time to join an existing team of Quality professionals to help develop the future processes of the manufacturing site. The successful applicant shall report directly to the Product QA manager and is a member of the site QA team, collectively responsible for maintaining and improving quality & compliance in the manufacture and support of our products and services.
- Bachelor’s Degree in relevant technical discipline (ideally Quality, Engineering or Science)
- 5+ years relevant experience in a regulated environment with a core appreciation of FDA regulations and Risk Management
- Strong leadership skills and ability to influence cross-functional teams to drive workscope to completion.
- Aptitude for systems level thinking, including development of standard operating procedures
- Core understanding of statistical analysis and design of experiment experience
- Familiar with statistical software packages e.g., Minitab
Work collaboratively with cross-functional stakeholders creating and ensuring value-streams comply with QMS requirements and production targets
Experienced in QMS covering a broad range of activities including process change, risk assessment, CAPA, non-conforming material, complaint handling, manufacturing and process deviations, non-conformance handling and validation
Core contributor to risk activities related to, verification and validation of product, process change, technology transfer plans, equipment commissioning, deviations, non-conforming material, out of tolerances, complaints, CAPA, continuous improvement changes, and post-production
Act as a key liaison and knowledge transfer champion among Quality Assurance, Manufacturing Engineering, R&D, Production and Documentation Control
Ability to develop into a mentor role for the quality, engineering and production teams is desirable
As a member of the site Quality team, you will focus on and be responsible for process design improvements and updating quality system procedures to achieve both fully compliant and lean processes
Using lean tools, own and lead quality projects that deliver quality, cost and process improvements
Assess manufacturing’s capability to meet quality requirements based on data analysis and internal audit
Experienced in the use of statistical analysis to support technical report writing to meet technical and regulatory standards of excellence