Senior Quality Engineer

CPL

Offaly

Our client, a global medical devices company based in the Midlands, are currently recruiting for a Senior Quality Engineer. This is a permanent role and will report to the Senior Quality Systems Manager. This role will suit someone with strong Quality Management Systems experience in a regulated environment either Medical Devices. Will be responsible for maintaining the Quality Management System, evaluating the manufacturing processes for the purpose of continued compliance, along with managing third party audits. Manage key elements of the Quality System to ensure compliance to relevant standards for the business including MDSAP, ISO13485, and FDA QSR. The role will take the lead in ensuring that the quality system is maintained and implemented in a compliant manner and areas of improvement are identified and implemented as required. This will involve coordinating and working with all functions in a collaborative manner where quality system compliance is dependent. Essential Functions: Provide guidance and support for determining regulatory/compliance strategies to meet the requirements of established certified standards, regulations and customer requirements. Maintain company documentation of procedures and ensure compliance with the company QA/RA integration plan. Support the various departments on compliance issues and CAPA investigations. Support and conduct internal audits. Act as senior investigator for critical quality issues as requested by Quality Management. Participate with the corporate remediation team to ensure compliance to the new MDR, to include risk management as EN ISO 14971:2012 Medical Devices – Application of risk management to medical devices, Product Standards, and other standards as required. Oversee annual audit schedules, ensuring audit teams are fully trained to all applicable standards and auditing requirements. Conduct or participate as needed in internal audits. Utilize benchmarking of best in class processes to provide information for continuous improvement. Participate in the site Quality Improvement Program, Minimum Requirements. BS or MS in Quality Management Systems, Science, Engineering, or related field. Minimum of 5 years of experience in a Regulatory Compliance and/ or Manufacturing Quality environment within the medical devices sector. Skills/Competencies: Knowledge of ISO Quality System Standards, MDSAP and FDA Quality System Regulation is required. Knowledge of risk management (FMEAs), process validation, statistical process control, and statistical sampling plans is desirable. Medical Device industry experience desired. Strong technical writing abilities. Ability to work with cross-functional teams, including production, quality, engineering and materials. If you are interested in applying for this role please call Linda on +353 1 2784671 or email ldunne@thornshaw.com. Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. www.thornshaw.com. This job originally appeared on RecruitIreland.com.

2262 days ago