Technology Transfer Engineer – Normal
Hero Recruitment
Cork
Contact: Caroline Kingston. Email: caroline@hero.ie. Telephone: 086 8395531. Technology Transfer Engineer – Normal. Our client, a pharmaceutical company in Cork are currently looking to recruit a Technology Transfer Engineer for their site. Main Duties & Responsibilities: Represent Quality as part of a cross functional team to ensure delivery of projects (NPI’s and Technology) into production with the highest level of quality, compliance, and adherence to timelines. Compile and execute validation protocols for new product/processes and software. Ensure correct implementation as per standard validation procedures. Re-validate as required due to engineering change, deviation analysis or upgrade in systems and material. Use of statistical analysis as part of validation activity and defining subsequent inspection and controls in production. Develop and utilise DFMEA/PFMEA and other QA risk analysis techniques in order to minimise potential risk during development/implementation activity. Liase with R & D to ensure Critical to Quality Characteristics are agreed and documented for all New Product Development. Lead Design for Inspection activities for all New Product Introduction to ensure latest technology is available to reduce Human Error. Lead QA input to Design for Manufacture activities on site. Ensure daily and project compliance with all Documented Quality systems i.e. FDA QSR’s and ISO 13485/9001 requirements etc. during all day to day. Provide technical assistance to carry out problem analysis/complaint investigation as required and define through negotiation effective corrective actions. Assist in problem solving for new products and established production process enabling reduction in compliance risks, scrap and reprocessing. Assist in the development, review and approve product, gauge, tooling and fixturing drawings. Maintain a good level of house-keeping in designated areas, and observe all Health and Safety at work requirements. Key Competencies Required. Culturally aware. Flexible. Team player. Good influencing skills. Project Management skills. Good generalist (experienced quality person. Methodical. Defuser, not inflamer. Good communicator. Politically sensitive. Travel Flexibility. Qualifications & Experience. A degree level or similar qualification in mechanical or industrial engineering. Minimum 1 years’ experience in a quality role within a regulated industry. Proven ability to successfully introduce new product development in the Medical Device Industry. Proven knowledge and ability regarding product verification and process validations. Proven knowledge of FDA and MDD GMP requirements regarding medical Devices. Proven experience and training in Mechanical Engineering processes. For further information on this Technology Transfer Engineer – Normal role in Cork please contact Caroline Kingston on 0868395531 / caroline@hero.ie. Check out all our open jobs on our HERO Recruitment website – www.hero.ie. Please Note: HERO Recruitment will not forward your details to any company without your prior approval. This job originally appeared on RecruitIreland.com.
2248 days ago