We are currently looking for a Senior Design Assurance Engineer to join our Galway site.

About the role:

A Senior Design Assurance Quality Engineer is responsible for assuring all requirements for the Product Development Process (PDP), Risk Management, Design Controls, Usability Testing, and External Manufacturer Production Controls which are met by:

          a.) Providing quality and compliance input to the project team for project decisions and deliverables (e.g. Design & Development Plan, Product Specification, Test Methods, Design Review, Design V&V, Usability Testing, SW Validation, Process Validation, and Labeling) whether internal, co-developed or externally manufactured

          b.) Leading the execution of Quality deliverables such as Risk Management Plan/Report, Hazard Analyses, Use and Design FMEA, Usability Testing, Design Validation, Quality Plans, and Field Assessment Plans

          c.) Providing quality and compliance input and coaching for product development and/or post market product sustaining activities, such as design changes, supplier auditing and surveillance, design concessions, product CE marking and safety certification, customer complaint investigations, NCEP’s, PIR’s and CAPA’s

          d.) Supporting Corporate Quality initiatives utilizing their PDP, Risk Management, and Design Controls expertise.

Responsibilities:

• Ensure appropriate Project/Sustaining Quality Deliverables are created and properly executed (e.g. Project Design & Development Plan, Risk Management Plan, Hazard Analysis, Use and Design FMEA, Field Assessment Plan, and Software Validation Plan if applicable). 
• Lead product usability and design validation efforts for new product development and design change projects.
• Provide quality and regulatory compliance guidance as needed to product development or design change project teams to assure country specific compliance to the laws and regulations of the targeted market for distribution.
• Provide product specific supplier and co-development quality assurance expertise during supplier audits, and through approval of supplier PDP and Design Controls deliverables.
• Measure and oversee the real-time continued quality of internal and external Component and Finished Good Suppliers.
• Provide key quality trending information and data for Management Review as required.
• Lead CAPA efforts, and apply sound, systematic problem solving methodologies identifying, prioritizing, communicating and driving resolution of quality issues (e.g., 5 why’s analysis, Is-Is Not analysis, and Six Sigma problem solving methodologies).
• Devise and support the implementation of effective quality assurance, process controls, statistical analyses, and metrics that assure products meet or exceed internal quality as well as statutory requirements.
• Champions 100% compliance to Company Policy and SOP’s.
• Advise management on potential improvements or enhancement to quality systems and processes in the company.
• Support internal and external regulatory audits.

Requirements/Qualifications:

• BSc in Science (such as Mechanical, Electrical, or Biomedical Engineering; MS)
• At least 5 years of Medical device engineering experience.
• In depth familiarity with the FDA, ISO, MDD/MDR and the medical device industry quality requirements associated with product development, design controls, and product risk management.
• Detailed understanding and working knowledge of US and International regulations including 21 CFR, 820, 210, 211, and 11 is required, as well as the Medical Device Directive, EN ISO 13485, EN ISO 14971, and EN 62366.
• Strong communication and presentation skills.
• Competent with use of Microsoft Office Suite, and Minitab Statistical Analysis software (or equivalent)