Job Title: Senior Quality Systems Engineer 

Location: County Westmeath, Ireland 

Company Overview: 

Our client, a leading medical device manufacturer in County Westmeath, is looking to hire an experienced Senior Quality Systems Engineer to join their dynamic team. The successful candidate will play a critical role in shaping the future of the company by driving quality improvements and ensuring compliance with industry standards. If you’re passionate about leading quality initiatives in a regulated environment, this is the perfect opportunity for you to make a real impact. 

Role Overview: 

As a Senior Quality Systems Engineer, you will have the opportunity to collaborate with a talented team of engineers and professionals, contributing to high-profile projects while driving improvements across the organisation. This is a key role, representing the Quality function in site management meetings, leading software validation efforts, and implementing significant process improvements. You will work on various projects aimed at enhancing quality standards, mitigating risks, and fostering a culture of continuous improvement. 

Key Responsibilities: 

• Quality Representation: Act as a representative for the Quality function during site management meetings and support the Quality Lead in daily operations. 

• Software Validation Leadership: Lead and manage the software validation process, ensuring all activities align with industry standards and regulatory requirements. 

• Process Improvement: Drive process improvements, cost-saving initiatives, and quality decisions through data analysis and the use of quality tools. 

• Project Leadership: Initiate and manage project plans, identify resource needs, and guide teams through technical activities such as risk documentation, process validation, and test methods. 

• Investigation Leadership: Lead investigations into Corrective and Preventive Actions (CAPAs) and Non-Conformance (NC), providing technical guidance and resolving compliance issues. 

• Auditing: Perform internal and supplier audits, and facilitate external audits from regulatory bodies, such as ISO and FDA. 

• Collaboration: Provide guidance to cross-functional teams, including Quality and Engineering disciplines, to implement robust solutions and ensure compliance with standards. 

Key Skills & Experience: 

• Educational Requirements: A Bachelor’s Degree or higher in Engineering or a Science-related field (minimum Level 8 qualification). 

• Experience: At least five years of experience working in regulated environments, preferably in the medical device sector, with knowledge of FDA or ISO 13485 standards. 

• Certifications: Lead Auditor or Internal Auditor certification is desirable. 

• Software Knowledge: Experience with software lifecycle tools such as JIRA, Qtest, and VERA is advantageous. Familiarity with Oracle, FactoryTalk, PEMAC, and Bartender will be a plus. 

• Personal Qualities: Strong leadership and communication skills with the ability to lead complex investigations, audits, and process improvements. 

Why Join Our Client? 

• Impactful Work: Take the lead on high-profile projects that directly influence the quality of life for end-users in the medical field. 

• Career Growth: Be part of a company that values professional development, offering continuous learning opportunities and a clear career progression path. 

• Collaborative Culture: Work alongside passionate, innovative, and diverse professionals dedicated to excellence in quality systems and process improvement. 

Quality of Life in County Westmeath, Ireland: 

County Westmeath offers a vibrant, welcoming community with a perfect blend of rural charm and modern amenities. Whether you’re an outdoor enthusiast or enjoy exploring historic towns, Westmeath provides a fantastic quality of life with access to beautiful natural landscapes, excellent schools, and thriving local culture. 

 

“Our Vision: To be recognised as the best STEM Contracting & Permanent Recruitment company and the Employer of Choice for top performing Recruiters 

 

For further information on this role please contact Lisa Lawlor on 0868395533 or email stem@hero.ie 

Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie/   

Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval. 

  

Data can only be transferred outside of the EEA on the basis of standards contractual clauses, to a country for whom an adequacy decision has been given by the European Commission or where the express permission of the data subject has been given. You have supplied us with your personal data in the process of applying for a position. Our client company may have personnel outside of the EEA who will review your data. We will apply the appropriate criteria in respect of the data transfer depending on the location of those personnel.”