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Senior Quality Engineer | Start up

  • Sector: Engineering
  • Contact Email:
  • Job Ref: 20608

This a fantastic opportunity for an experienced Senior Quality Engineer to join an innovative and exciting start-up here in Galway.

The role:

As the Senior Quality Engineer, you will be responsible for managing key quality personnel and providing technical support for the manufacture of existing products and support of design and development of new products while demonstrating and promoting a commitment to improving patient safety, customer satisfaction, and product quality.



  • Ensure NCR/CAPA system is maintained
  • Working with other key functions, develop Quality Plans for principal products and product lines.
  • Maintain control of nonconforming material and product.
  • Develop Inspection Plans and supporting documents that specify inspection and test requirements and sampling levels.
  • Interface with other functions in a team environment providing Quality systems input & leadership.
  • Provide technical support for the manufacture of existing products and the growth and development/transfer of new products/technologies.
  • Monitor the suitability and effectiveness of the Quality System and assure compliance with current US and international regulations and ISO standards.
  • Direct continuous improvement of the system to meet the evolving expectations of customers, business partners, and regulators.
  • Identifies opportunities to improve organizational systems and processes to save costs, improve efficiency, maintain compliance, or increase customer satisfaction
  • Actively participates in specification development in relation to design input development
  • Provide guidance to project teams and engineers in the processing and development of protocols, reports, procedures, deviations, and change requests on a day-to-day basis for identified projects
  • Develop process validation plans, protocols, risk assessments, and reports
  • Manage and executes key elements of Production Sterilization, Product Release, etc.
  • Identify, interpret & manage changes in systems or procedures, which could potentially affect compliance as they relate to assigned projects.
  • Ensures internal audits and other activities covered under XXX company’s Quality Manual, Policies & Procedures are executed.
  • Review change control for designated projects for quality assurance implications
  • Manage supplier approval and qualification of new/revised items which includes inspection method development and validation as well as correlation with supplier’s methods, supplier audits, management of supplier corrective and preventative actions
  • Reporting the performance of the quality system and any need for improvement to executive management; and
  • Promote awareness of regulatory and customer requirements and Serve as the company's liaison with customers and other outside concerns on matters related to product quality and reliability.
  • Support submission of QMS documents and records
  • Maintenance of documentation and records related to the Manufacturer’s QMS.


  • Knowledge of QMS regulation (ISO 13485 or 9001) Knowledge of risk management
  • Extensive knowledge of quality management systems and current international and European regulations/standards with respect to medical devices.
  • Design for Manufacturing and lean manufacturing experience is a plus.
  • Experience in the medical device or another highly regulated branch with experience More than 5 years working experience in a quality role in a pharmaceutical/Medical Device environment.
  • Excellent interpersonal and communication skills with good leadership abilities; high level of self-motivation
  • Demonstrable ability to work in a multi-disciplinary, regulated environment.

For more information or a confidential discussion about this role please contact Michelle McInerney


091 706 717