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 variables—and their interactions—are 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.
What’s 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.
What’s Next
Apply now by clicking the “Apply Now" button or contact us for a confidential discussion. If the job isn’t quite right but you are looking for something similar, please get in touch. We also have multiple Temp, FTC, and Contract jobs available.