About
You can get further details about the nature of this opening, and what is expected from applicants, by reading the below.
We are seeking a proactive and detail-oriented professional to play a key role in supporting manufacturing excellence, process improvements, and product quality initiatives.
This is an exciting opportunity to work in a collaborative environment where you'll contribute to continuous improvement projects.
Key Responsibilities: Review, plan, and coordinate the implementation of engineering and quality change controls.
Partner with Manufacturing Engineering teams to complete risk assessments, update work instructions, and develop FMEAs for product line extensions and process improvement initiatives.
Assess change controls for validation impact and ensure compliance with quality and regulatory requirements.
Apply statistical analysis techniques to support validation activities, process optimisation, and data-driven decision-making.
Collaborate with Manufacturing Engineering to develop validation strategies and sampling plans for both new and existing product lines.
Lead investigations into manufacturing and quality issues, driving effective problem-solving and resolution to maintain production efficiency.
Provide quality leadership, CAPA investigations, and product disposition activities.
Support continuous improvement initiatives focused on enhancing product quality, operational efficiency, and compliance.
Requirements 35 years' experience in the Medical Device industry.
Strong understanding of change control processes and validation impact assessments.
Excellent communication skills, with the ability to explain technical concepts clearly to both technical and non-technical stakeholders.
Experience with risk management tools, including FMEA Knowledge of root cause analysis and structured problem-solving methodologies.
Proficiency in Microsoft Office applications, particularly Excel, Word, and PowerPoint.
Desirable Skills Familiarity with statistical analysis tools and techniques, including Pareto charts, trend analysis, and process monitoring.
Experience supporting validation activities in a regulated manufacturing environment.
Strong analytical mindset with a passion for continuous improvement.
Proven ability to work cross-functionally and drive projects to successful completion.
If the above role is of interest to you and you feel you have the required experience, then please contact us today.
If you are living in Ireland and hold a VALID WORK PERMIT, we would love to hear from you, If however, you do not hold a valid work permit unfortunately we will not be in a position to assist you with your job search.
Celtic Careers is proud to be an Equal Opportunity Employer.
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Medical Device industry,change control processes,risk management tools Skills: 3
- 5 Years Medical Device Experience change controls review statistical tools
TPBN1_IJ
Languages
- English
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