About Your New Employer Join a leading medical device manufacturer driven by innovation and a mission to improve patient lives.
Enjoy excellent worklife balance with a 4-day work week (MondayThursday) and the opportunity to grow your career in a high-performing, collaborative environment.
About Your New Job As the Quality Engineer, you will be a key member of the Quality team of 14, responsible for maintaining and improving the sites Quality Management System.
Youll work closely with R&D and Process Engineers to ensure smooth, timely, and cost-effective transitions of products through development, approval, and manufacturing scale-up.
In this role, you will: Partner with R&D and Process Engineering teams to support product development, transfers, and process improvements.
Promote compliance and excellence to meet customer requirements and regulatory standards (FDA, ISO *****, MDR).
Lead and execute equipment, process, and product validations in line with quality and regulatory expectations.
Conduct root cause analysis, manage non-conformances, and implement effective CAPAs to drive continuous improvement.
Support internal and supplier audits, ensuring findings are addressed and preventive actions are in place.
Manage and investigate customer complaints, performing failure mode analysis and implementing quality improvements.
Provide day-to-day Quality support for manufacturing operations, ensuring product and process integrity.
This is a great opportunity for a motivated Quality professional who enjoys problem-solving, collaboration, and making an impact in a regulated, innovative environment.
What Skills You Need A degree in Engineering or Quality Assurance (or equivalent experience).
A minimum of 3 years experience in a Quality role within a cleanroom or regulated manufacturing environment.
Strong working knowledge of medical device regulations (FDA, ISO *****, MDR).
Excellent analytical, communication, and interpersonal skills, with the ability to influence cross-functional teams.
Whats on Offer Days and Permanent, onsite role based in Ballinasloe, Co.
Galway.
4-day work week (MondayThursday) for a better worklife balance.
Competitive salary, career development opportunities, and a supportive company culture focused on innovation and quality.
Whats Next Apply now by clicking the Apply Now button or contact Tina at Sigmar Recruitment for a confidential discussion about this role and other similar opportunities.
Benefits: Paid Holidays Compressed hours