Quality Systems Engineer

3 weeks ago

Dublin, Dublin City, Ireland Collins McNicholas Recruitment Full time

We are delighted to introduce a compelling opportunity to join our esteemed client in the medical device industry as a Quality System Engineer on an initial 12 month contract. 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.

As the 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.
  • 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.

Requirements:

  • Degree in Engineering or Science related field (minimum level 8)
  • Lead Auditor or Internal Auditor certification an advantage.
  • 4 years' experience working in a regulated environments, specifically medical device

FULL SPEC ON APPLICATION

If you are interested in learning more about this fantastic opportunity, please contactCathal Herron:


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