Quality Engineer

Sigmar Recruitment

Galway

Our client based in Galway city is a smaller medical device manufacturer. They are now seeking suitably qualified and experience Quality Engineers to join their team. The successful candidate will be responsible for providing quality engineering support for processes, materials, and products. Assures thatquality standards are maintained and assist with the implementation and compliance of the qualitymanagement program. Support company goals and objectives, policies and procedures, quality systems, andFDA regulations. For more information call Racheal on 091 455306 for a confidential chat. Responsibilities: Provide quality input to support manufacturing process such as in-process inspection, in-process monitoring, Sterilisation signoff, Final product release and GMP activities (e.g. GMP audits and GMP/GDP Training. Support Design and development through QA test lab activities such as product testing, test procedure improvements, test method validation. Use and establish problem solving / analysis techniques and other quality control tools to aid improvement activity investigating root cause of quality issues in manufacturing and aid decision-making. Support vendor management through new supplier evaluation, vendor audits, implementing SCARs. Identify opportunities for quality system and quality process improvements and work with task teams in achieving these. Independent review for critical services e.g. environmental monitoring, incoming inspection etc. Liaise with Design Engineering on the implementation of validation process including provision of sampling plans, data processing or analysis for validation or risk assessment including Use, Design & Process FMEAs as required. Assist in the analysis and resolution of problems that may reduce the efficient running of production lines. Design and implement quality control process sampling systems, procedures, and statistical techniques. Ensure continuous compliance for packaging integrity and label control and compliance. Supervision of quality inspectors / operators / Technicians Personnel management (including time & attendance. Training plan development. Personnel mentoring. Develop and manage fully regulatory compliant calibration system. Establish and maintain an environmental monitoring program to ensure continued compliance of cleanrooms. Generation and/or review of quality and technical documentation to support continued validation status of cleanroom and sterilisation cycle. Customer service - External: Provide support in the resolution of product complaints, product problems, or safety issues. Coordinate and maintain the Corrective Action Program to assure appropriate investigation and implementation. Customer service - Internal: Develop harmonious working relationships with all functions, and ensure employees have the necessary information (data analysis) and resources to effectively perform their jobs. Requirements: Education. Bachelor’s degree in Science or Mechanical, Materials, Polymer, or Biomedical Engineering, or related technical field. Experience. A minimum of 3 years Medical device industry experience. PTCA / PTA experience strongly preferred. An understanding of the Medical Device Directive (93/42/EEC), ISO13485 and Quality System Regulation (21CFR 820) for Medical Devices. Competencies / Skills. Problem Solving (using recognised tools) and decision making (makes sound factual decisions. Risk Management including FMEA generation. Demonstrated experience in regulated design environments, specifically medical device development, or,FDA or ISO registered work environments. Change control management; design, process and system. Six Sigma expertise demonstrated in the manufacturing and design of new products is highly desired. Good communication and interpersonal skills -communicate highly technical information, both verbally and in. writing, to both non-technical and technical associates. Quality of work; maintains high standards despite pressing deadlines. To apply send your CV or call Rachael on 091 455306 for a confidential chat to find out more. All applications are dealt with in the strictest of confidence. Sigmar will never send your CV to a third party without your consent. This job originally appeared on RecruitIreland.com.

2795 days ago