QA Engineer

Bd Medical

Enniscorthy, Wexford

Reporting to the Quality Manager responsible for Quality Systems, the Quality Engineer will be dedicated to quality system development, and advancement ensuring greater compliance across the facility. They will play a key role in the development and execution of plans to ensure compliance to the new MDR regulations and also ensure systems developed will allow for continued compliance to standards as they are revised. The role requires a high level of ownership and enthusiasm. Summary of Position with General Responsibilities: Reporting to the Quality Manager responsible for Quality Systems, the Quality Engineer will be dedicated to quality system development, and advancement ensuring greater compliance across the facility. They will play a key role in the development and execution of plans to ensure compliance to the new MDR regulations and also ensure systems developed will allow for continued compliance to standards as they are revised. The role requires a high level of ownership and enthusiasm. Essential Job Functions: Assess compliance to global and corporate quality management system standards and regulations including MDR, ISO 13485, CFR 11820 and CMDR. Review and assess risk management and validation requirements throughout product realisation. Perform risk management and validation activities in support of quality system compliance. Implement changes in quality management system policies and procedures in line with best practice and systems excellence. Alignment of the quality system with changes in global and corporate quality management standards, policies and regulations. Effectively communicate with internal and external customers. Participate in and support external audit activities. Drive CAPA and continuous improvement activities as required. Perform internal audits, identify gaps and recommend improvement measures. Development of robust action plans, projects and verification activities for prevention of compliance findings across all aspects of the quality system. Developing detailed gap analysis and executing plans to maintain compliance to all internal and external standards and procedures. Prioritising improvement areas based on risk assessments. Systems focus on all key aspects of product realization including R&D, Manufacturing and Logistics activities. Education and/or Experience: Third level technical / Science qualification Min 3 years in the medical device or pharmaceutical industry Knowledge of quality management systems ISO 13485, GMP, etc Excellent interpersonal skills with the ability to work in a team environment and work under own initiative to targets and deadlines Problem solving techniques with excellent organisational skills Dedication to excellence, flexibility and adaptability to change. Attention to detail and adaptability. This job originally appeared on RecruitIreland.com.

1963 days ago