Senior Quality Engineer
Senior Quality Engineer- Medical Devices- Limerick
Our client a leading medical device company based in Limerick are looking for a Senior Quality Engineer to join their team. The successful candidate will be assigned an 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.
- 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
- Product test and release planning, change management and audit
- Critical thinking and technical writing
- 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
- Leads by example and demonstrates agreed behaviours.
- Aligns goals and objective setting for the VS in collaboration with management
- Executes on Lean/Shingo initiatives bringing everyone else on board.
- Is committed to develop, coach, motivate self and team.
- Leads the VS based on influencing skills without having the hierarchy of all team members
- Builds relationships with key stakeholders in the company and addresses their needs of communication and information
- Ensure full compliance with regulatory requirements.
- Ensure Quality and EHS policies and procedures are adhered to at all times.
Education and Experience:
- Degree in a Science, engineering/ quality related discipline
- 8+ years Quality technical experience in a similar environment
- Certified QE, desirable
- Technical report writing skills
- Risk Management tools and Process validation.
- Statistical analysis
- Structured Problem-Solving tools.
- Understanding of Lean Principles, LSS Green Belt certified desirable