An exciting opportunity for an experienced Senior Quality Engineer to join our client, a leading medical device company based in Annacotty, Limerick on a permanent contract. This role requires strong people management skills, strong regulated experience and a degree in science/engineering.
Quality Leadership in assigned area to develop and operationalize the quality strategies for products, processes and/or systems to assure Customer and business requirements are delivered. Driving QMS and Customer requirements throughout product lifecycle including NPD, NPI, Commercialization, Sustaining and End of Life. During all phases ensure effective quality input, review and release of documentation and communication with all stakeholders. Driving compliance within the Value Stream (VS) to all GMP and QMS requirements.
The Senior Quality Engineer will excel in the technical competence required for the role, including:
Specification development, CTQ mapping, test method development and validation, process validations and implementation of CCP within the process, using error proofing, process monitoring, SPC.
Complaint handling, NC management, Risk and Impact assessment, Root cause investigation and solution development and verification.
The Senior Quality Enginner will product test and release planning, change management and audit.
Quality lead on multi/cross functional project teams to achieve milestones and results.
Represents company in Customer interactions relating to product, process and system quality elements in a professional, constructive, and commercially aware manner.
Ensures that customer product requirements are defined and implemented within the site QMS.
Proactively engage in new product development to ensure a smooth transition from development to production.
Drives continuous improvement across the board and takes initiatives to make things better every day.
Owns and drives the Safety/Quality/Service/Cost Metric with VS Leader team.
Degree in a Science, engineering/ quality related discipline.
6+ years Quality technical experience in a similar environment.
Certified QE, desirable.
Technical report writing skill.
Risk Management tools and Process validation.
For a confidential discussion and more information on the role, please contact Alicja Burchardt.