Senior Technology Transfer Engineer
Reporting to the QE Leader, this position leads from a Quality perspective.
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 stakeholders for successful project completion.
Main Duties & Responsibilities:
* 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.
* Compile and execute validation protocols for new products/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 statistical analysis as part of validation activity and defining subsequent inspection and controls in production.
* Develop and utilize DFMEA/PFMEA and other QA risk analysis techniques to minimize potential risk during development/implementation activity.
* Liaise 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 QSRs and ISO requirements, etc., during all day-to-day activities.
* 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 processes enabling reduction in compliance risks, scrap, and reprocessing.
* Assist in the development, review, and approval of 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 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
Skills:
* Quality validation
* Document approval
* Document review