Job Title: Senior Technology Transfer Engineer
Overview
The Senior Technology Transfer Engineer 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 to ensure timely communication and successful project completion.
Main Responsibilities:
1. Represent Quality as part of a cross-functional team to deliver projects (NPIs and Technology) into production with the highest level of quality, compliance, and adherence to timelines.
2. Compile and execute validation protocols for new products/processes and software, ensuring correct implementation as per standard validation procedures.
3. Develop and utilise DFMEA/PFMEA and other QA risk analysis techniques to minimise potential risk during development/implementation activity.
4. Liaise with R&D to ensure Critical to Quality Characteristics are agreed and documented for all New Product Development.
5. Lead Design for Inspection activities for all New Product Introduction to reduce Human Error.
6. Assist in problem solving for new products and established production processes to reduce compliance risks, scrap, and reprocessing.
7. Maintain a good level of house-keeping in designated areas and observe all Health and Safety at work requirements.
Key Competencies:
* 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
Requirements:
* A degree-level or similar 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
* Proven experience and training in Mechanical Engineering Processes