Technology Transfer Engineer
Orion Group are looking for a Technology Transfer Engineer for our multinational medical devices client based in the Cork area on an initial 12 month contract with the potential to extend.
- Job Purpose
- The job holder will lead the QA element of process / technological improvements, new product introduction and product transfers in conjunction with local Quality, Operations and R&D personnel ensuring timely communication to all stake holders to effect successful project completion.
Main Responsibilities of the role
- 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
Desired Experience and Background of the successful candidate
- 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.
- Culturally aware
- Team player
- Good influencing skills
- Project Management skills
- Good generalist (experienced quality person)
- Defuser, not inflamer
- Good communicator
- Politically sensitive
Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.
Posted 37 days ago