Quality Systems Engineer

We are looking for an experienced Quality Systems Engineer to join our client in Athlone. As Quality Systems Engineer, you will have the opportunity to put your curiosity to good use and collaborate with some of the most innovative and diverse people in the world. Here's how to make an impact:

• Representing Quality function in Site Management meetings as required.
• Acting as a delegate for the Quality Lead.
• Leading and implementing significant process improvements, projects and cost saving initiatives using data & quality tools to drive quality decisions. Initiating project plans, identifying resource allocations, performing and guiding technical activities such as risk documentation, procedural updates, test methods, process / software validation that have major importance to the business.
• Initiating, reviewing, approving, and providing guidance on change controls and change control process.
• Performing, analysing and interpreting statistical data using a detailed understanding of statistical tools and methods.
• Leading investigations and providing technical guidance to peers in relation to CAPAs and NC and to address compliance issues and providing guidance to engineering.  Leading the implementation of robust solutions. 
• Ensuring QMS is implemented and adhered to by completing independent assessment of QMS documentation as required. Independently assess and provide guidance to Quality and Engineering disciplines.
• Provide periodic training for company personnel on the company’s Quality System processes and procedures.
• Performing and leading Internal and Supplier Audits.
• Facilitating and participating in external regulatory body audits, e.g. ISO and FDA
• Implementing Key Performance Indicators within the Quality Assurance area to align with site and global quality objectives.
• Complete data analysis for Management Review.
• Co-ordinate collection of data for PMS.
• Actively lead QMS Process Improvement Projects
• Complying with all relevant training required and adhere to relevant associated documentation.
• Abiding to Environmental, Health and Safety (EHS) Policies and any relevant other EHS documentation.
• Following strict adherence to the requirements of CGMP.
• Ensuring compliance to quality systems and all applicable regulations/standards, and internal procedures.

 

Your Skills and Expertise 

To set you up for success in this role from day one, we are looking for candidates who must have the following qualifications:

• Degree in Engineering or Science related field (minimum level 8)
• Lead Auditor or Internal Auditor certification an advantage.
• Five (5) years’ experience working in a regulated environments, specifically medical device, FDA or ISO 13485 registered work environments is preferable.
• Strong computer skills (MS Excel, PowerPoint, Word etc.)
• Strong knowledge of statistical tools and techniques
• Strong knowledge of FMEA’s (Failure Mode and Effects Analysis) and root cause analysis tools.
• Strong knowledge of problem solving techniques.
• Ability to effectively communicate highly technical information, both verbally and in writing, to both non-technical and technical associates.
• Knowledge of the Quality System Regulation and associated regulations and standards.

For further information on this role in Galway please contact Katie Kilbane on +353 86 1283368 or email network@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 you data. We will apply the appropriate criteria in respect of the data transfer depending on the location of those personnel.