Quality Engineer II About Your New Employer This company is a global leader in medical device manufacturing, committed to transforming lives through innovative medical solutions.
With a strong presence in Cork, Ireland, the company offers a dynamic and collaborative work environment.
About Your New Job as a Quality Engineer: Ensure consistent, well-controlled workflows across shipping and packaging operations, with emphasis on risk mitigation, yield optimization, reduction of customer issues, error-proofing, cost-efficiency initiatives, and opportunities for process automation.
Meet quality, cost, and throughput targets by ensuring all process variablesand their interactionsare clearly defined, and all potential failure modes are identified and addressed.
Maintain compliance with applicable current Good Manufacturing Practices (cGMPs) and the requirements of relevant regulatory bodies for regulated products.
Provide support on quality-related matters, including regulatory expectations, statistical methodologies, and sampling strategies.
Apply appropriate statistical tools to monitor and improve process performance (e.g., SPC, capability analysis, sampling methods).
Review and approve change requests related to products, processes, and quality systems; evaluate customer feedback and complaint trends.
Establish validation requirements, and prepare or approve validation plans, protocols, and reports; assemble necessary regulatory documentation.
Assess Material Review Board (MRB) data and identify corrective actions when warranted.
What Skills You Need Minimum of a Bachelor of Science Degree in Engineering/Technology.
3-4 years of experience in a manufacturing environment, with direct experience in a QA environment (preferably GMP regulated).
Experience in the medical device industry is an advantage.
Whats on Offer Competitive salary and benefits package.
Opportunities for career growth and development within a leading global company.
A collaborative and innovative work environment focused on quality and continuous improvement.
Whats Next Apply now by clicking the Apply Now" button or contact us for a confidential discussion.
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