Job Summary
We are seeking a Senior Technology Transfer Engineer to lead quality initiatives from a technical perspective. This individual will be responsible for ensuring the timely delivery of projects, including new product introductions and technology transfers, while maintaining the highest level of quality, compliance, and adherence to timelines.
Key Responsibilities
1. Represent Quality as part of a cross-functional team to ensure the successful delivery of projects into production.
2. Compile and execute validation protocols for new products, processes, and software.
3. Ensure correct implementation of standard validation procedures and re-validate as required due to engineering changes or upgrades.
4. Develop and utilize DFMEA/PFMEA and other QA risk analysis techniques to minimize potential risks during development/implementation activities.
5. Liaise with R&D to ensure Critical to Quality Characteristics are agreed and documented for all New Product Development.
6. Lead Design for Inspection activities for all New Product Introduction to reduce Human Error.
7. Ensure daily and project compliance with all Documented Quality systems, including FDA QSRs and ISO requirements.
8. Provide technical assistance for problem analysis/complaint investigation and define effective corrective actions.
9. Assist in problem solving for new products and established production processes to reduce compliance risks, scrap, and reprocessing.
10. Maintain a good level of house-keeping in designated areas and observe all Health and Safety at work requirements.
Qualifications and Experience
* A degree-level qualification in mechanical or industrial engineering.
* Minimum 5 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.