Job Description:
The Senior Technology Transfer Engineer will lead the QA element of process/technological improvements, new product introduction, and product transfers.
Organizational Interfaces:
* All World Wide Facility Quality, Operational, and R&D
* Vendor management personnel
Main Duties & Responsibilities:
1. Represent Quality as part of a cross-functional team to ensure delivery of 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.
3. Ensure correct implementation as per standard validation procedures.
4. Re-validate as required due to engineering change, deviation analysis, or upgrade in systems and material.
5. Use statistical analysis as part of validation activity and defining subsequent inspection and controls in production.
6. Develop and utilise DFMEA/PFMEA and other QA risk analysis techniques to minimise potential risk during development/implementation activity.
7. Liase with R&D to ensure Critical to Quality Characteristics are agreed and documented for all New Product Development.
8. Lead Design for Inspection activities for all New Product Introduction to ensure latest technology is available to reduce Human Error.
9. Lead QA input to Design for Manufacture activities on site.
10. Ensure daily and project compliance with all Documented Quality systems i.e. FDA QSRs and ISO requirements etc.
11. Provide technical assistance to carry out problem analysis/complaint investigation as required and define through negotiation effective corrective actions.
12. Assist in problem solving for new products and established production process enabling reduction in compliance risks, scrap, and reprocessing.
13. Assist in the development, review, and approve product, gauge, tooling, and fixturing drawings.
14. 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
Qualifications & Experience:
* 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.