Quality Systems Engineer Hybrid

at  Collins McNicholas

Sector: Science & Pharma
Contact Email: gillian.nicholson@collinsmcnicholas.ie
Job Ref: 22717
We are delighted to introduce a senior Quality opportunity to join our esteemed client in the medical device industry as a Quality System Engineer. Our client is a leader in the field, dedicated to producing high-quality medical devices and advancing healthcare. If you have a passion for quality assurance, a proven track record of excellence, and a desire to drive innovation, we invite you to explore this role and become a vital part of our growing team.Our client is a well-established and reputable player in the medical device industry. With a commitment to improving healthcare through cutting-edge technology, they have consistently delivered high-quality, life-saving products to patients around the world. You will also get the opportunity to see other functions of the organisation such as Sterile Manufacturing, medical device equipment from a product knowledge perspective.
This position will be a senior Quality position within the team. As the more experienced Quality System Engineer, you will play a pivotal role in ensuring the quality and safety of our medical devices.

REQUIREMENTS:

• Degree in Engineering or Science related field (minimum level 8)
• Lead Auditor or Internal Auditor certification an advantage.
• 5 years’ experience working in a regulated environments, specifically medical device
• 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.
• Attention to detail and accuracy is essential.

• Representing Quality function in Site Management meetings as required.
• Acting as a delegate for the Quality Lead.
• Lead investigations and providing technical guidance to peers in relation to CAPAs and NC and to address compliance issues and providing guidance to engineering.
• 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.