Quality Systems Engineer

CPL

Roscommon

On behalf of my client, a medical device company, I am recruiting for a Quality Systems Engineer. This is a permanent role. The successful candidate will be responsible for the following: Provide regulatory support for new product and support to Operations, Sterilisation and Labelling/Packaging. Review and update of Regulatory documentation to ensure compliance with current ISO standards, relevant FDA guidelines and EU Directives. Process Audits of the manufacturing lines to ensure the product being manufactured complies with all requirements, and that the Equipment/Process in use complies with the relevant EXPS (Set-Up Sheets) and Standard Operating Procedures. Generation and Revision of EXPS (Set-Up Sheets) and Tube Specifications (Product Specifications) to ensure all relevant Quality and Process/Equipment requirements are captured. Identify and suggest improvements to current equipment, processes, and procedures to streamline the manufacturing activities while ensuring high standards of quality. In conjunction with the Manufacturing Engineer, provide advice and support to processes that require investigation or development with the goal to improve and make robust. Be an active Team Member on Continuous Improvement Projects by delivering on actions committed to, critiquing current methods, and suggesting alternatives/improvements. Support the Manufacturing Engineer and cross functional teams on the collation of data and the resolution of processing issues. Actively promote Quality within the Manufacturing group, and assist the Quality Department on introducing initiatives into the Manufacturing Department. Lead Manufacturing Driven initiatives with respect to quality within the department. Batch Record/Lot History Review to ensure Product Compliance/GMP/GDP are as per relevant procedures prior to final QA Release. Maintain effective open communication within the team and foster cross- functional relationships. Applications are invited form candidates with the following background and experience: Primary degree or equivalent in Engineering/Science discipline. Medical device manufacturing experience is essential, 4 plus years. Hands on experience in Medical device manufacturing are essential. Must have a good working knowledge of production and quality system requirements in the health care industry (13485:2003 and FDA QSR Parts 820. A Green or Black Belt in Lean Six Sigma would be a distinct advantage. For a full Job Spec and to apply for this role please call Deirdre on +353 1 2784671 or e-mail dbolger@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.

2560 days ago