Quality System Engineer

A Quality Systems Engineer is required by CareerWise Recruitment for our Galway based client. Reporting to the QA/RA Manager this person will initially be responsible for a project designed to bring the QMS (Quality Management System) into compliance with the current US FDA QMSR. Working in the QA Dept, and directed by the QA/RA Manager, this person will take day to day responsibility for the change and development of current systems ensuring that they are fully compliant to US regulations. This will involve conducting gap assessment identification of options for changes, discussion/agreement with stakeholders in the company and outside, and the writing and implementation of new procedures.

Role of this position

• Take a lead, hands on role in the development of the Company QMS to make it fully compliant with FDA QSMR.
• Plan the process of Development of the QMS from initial Gap Analysis to Final Compliance.
• Writing of New and Revision of existing Procedures and Systems will be a key function.
• Provide monthly project progress reports to management.
• Take part in fielding third party QMS audits.
• Support and deliver continuous improvements and to employ problem solving tools including root cause analysis and CAPA identification.
• Prepare Quality reports for Quality meetings and management reviews.
• Act as an effective team member in supporting quality disciplines, decisions and practices.
• Apply sound, systematic problem solving methodologies in identifying, prioritizing, communicating and resolving quality issues.
• Ensure regulatory compliance to GMP for all medical device regulatory agencies.
• Suggest changes in procedures and standards to facilitate work efficiency and maintain quality.
• Conduct internal quality audits to ISO 13485 and GMP requirements.
• Oversee and be actively involved in all QA office systems and functions (after project completion).
• Report on Key Performance Indicators (KPIs) in order to adhere to process and prevent occurrence of any non-conformity relating to product process or system (after project completion).
• Undertake special projects as required.
• The ability to develop procedures which will be appropriate for the Company while at the same time achieving compliance with QSMR will be critical.
• This will require a flexible, open-minded and pragmatic “solutions” based approach.
• Be part of project teams. Deliver on commitments to schedule and budget.

JOB REQUIREMENTS

• Bachelor’s Degree in Engineering, Science, Quality Management, or a related field.
• At least 4 year industry experience in Medical Device Manufacturing within US FDA compliant companies.
• Previous experience within the Medical Device industry in Quality/Engineering is essential.
• Detailed knowledge and understanding of ISO 13485 & US FDA QSMR is essential.
• Certification in Quality Management (e.g., ISO 13485 Lead Auditor) is preferred.
• Significant experience and ability in writing and developing quality procedures will be key.
• Excellent computer skills (Word, Excel, PowerPoint and Access).
• Excellent communication (both verbal and written) and interpersonal skills.
• Strong written, oral and presentation skills.
• Strong critical thinking, solid decision making and problem-solving skills.
• Flexible, highly motivated individual.