Direct message the job poster from Sigmar Recruitment
This employer is Galway based well established medical devices company designing, developing and manufacturing balloon and stent catheters and sells primarily to the Japanese market. They have subsidiaries in Japan, Ireland and USA.
About Your New Job as a Quality Systems Engineer:
Initial responsibility for a project designed to bring the Quality Management System into compliance with the current US FDA QMSR. Working in the QA Dept, and directed by the QA/RA Manager, the successful candidate will drive day to day responsibility for the change and development of current systems ensuring that they are fully compliant to US regulations. It will involve conducting gap assessment of options for changes, discussion/agreement with internal and external stakeholders, writing and implementation of new procedures. When the project is complete (expected 18 months – 2 years), this person will step into a system maintenance and system management role, overseeing the running of QA based systems such as document control, completion of 3rd party audits, oversight of the internal auditing process and other systems as required.
* Lead the development of the Quality Management System (QMS) to ensure full compliance with US FDA QMSR.
* Plan and execute the QMS development process, from initial gap analysis to final compliance.
* Write and revise procedures and systems to meet regulatory requirements.
* Provide monthly project progress reports to management.
* Participate in third-party QMS audits and support continuous improvement initiatives.
* Prepare quality reports for meetings and management reviews.
* Apply systematic problem-solving methodologies to identify, prioritize, communicate, and resolve quality issues.
* Ensure regulatory compliance to GMP for all medical device regulatory agencies.
* Conduct internal quality audits to ISO 13485 and GMP requirements.
* Oversee QA office systems and functions after project completion.
* Report on Key Performance Indicators (KPIs) to prevent non-conformities.
What Skills You Need to succeed as a Quality Systems Engineer:
* At least 4 years of industry experience in medical device manufacturing within US FDA compliant companies.
* Bachelor's degree in Engineering, Science, Quality Management, or a related field.
* Detailed knowledge and understanding of ISO 13485 and US FDA QSMR.
* Certification in Quality Management (e.g., ISO 13485 Lead Auditor) is preferred.
* Significant experience in writing and developing quality procedures.
* Excellent computer skills (Word, Excel, PowerPoint, and Access).
* Strong communication and interpersonal skills.
* Critical thinking, decision making, and problem-solving skills.
* Flexible and highly motivated individual.
What’s on Offer for Candidates for a Quality Systems Engineer:
* Competitive salary – range between 48k – 56k
* VHI Healthcare cover and Dental Plan.
* Life Assurance and Pension contributions.
* Paid Maternity and Paternity leave.
* Reward and Recognition Programme.
* Employee Assistance Programme (EAP).
* Learning and Development opportunities.
* Corporate Discounts in nearby amenities.
* Sports and Social club.
* Wellbeing events and partially subsidised canteen.
* Convenient location with multiple bus routes and free parking.
* Bike to work scheme and bike sheds available.
What’s Next
Apply now by clicking the “Apply Now
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