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.
Responsibilities:
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.
Coordinate 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.
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.
Some Benefits on offer:
Hybrid working flexibility on days
Company Pension Contribution up to 10% company contribution
Life Assurance – 4x salary
Family Healthcare
Long Term Disability benefit
25 days holiday increasing with service
FULL SPEC ON APPLICATION
If you are interested in learning more about this fantastic opportunity, please contact Gillian Nicholson.
gillian.nicholson@collinsmcnicholas.ie
(090) 645 0665