Job Title: Quality Engineer
Location: Galway
Job Summary:
A great opportunity has arisen for an experienced Quality Engineer to join a fast-paced and regulated manufacturing environment. This role involves close collaboration with cross-functional teams to support product development, process improvements, supplier management, and the overall maintenance of the Quality Management System.
Key Responsibilities:
- Work closely with various departments to support manufacturing, new product introductions, process transfers, and ongoing improvements.
• Review and contribute to design verification activities, including protocols, reports, and quality documentation throughout product development stages.
• Assist with process validation using risk analysis and statistical tools, ensuring all work meets regulatory and internal quality standards.
• Support supplier qualification, performance assessment, and audit processes.
• Create and manage documentation for non-conformances, deviations, customer complaints, and CAPAs, ensuring timely and effective resolution.
• Oversee validation and monitoring related to particulate and contamination control.
• Handle change control activities, ensuring appropriate actions and timely completion.
• Maintain training records and support the coordination of training activities.
• Recommend and implement updates to procedures and work instructions as part of continuous improvement efforts.
• Drive metrics reporting and trend analysis for quality system performance indicators.
• Contribute to internal audit preparation and execution, as well as other QMS-related tasks.
Qualifications & Experience:
- A degree in Engineering, Science, or a related discipline.
• At least 3 years of experience in a quality-related role within a medical device or regulated manufacturing setting.
• Strong problem-solving abilities and technical acumen, with a keen attention to detail.
• Excellent communication and teamwork skills.
• Proficiency in Microsoft Office tools such as Excel, Word, and PowerPoint.
What’s Next?
- Apply now by clicking “Apply Now” or contact me at +353 21 461 5740 or via email at pkiely@sigmar.ie
• If this opportunity isn’t quite right, feel free to get in touch to discuss other openings that may suit your background.
