From Roert Walters, we are looking for a Process Engineer Quality Assurance Technician responsible for the achievement of the validation master plan and the calibration programme to ensure the effectiveness of the QMS and ensure the proper functioning of the internal calibration laboratory.
Work alongside product managers, project managers, and developers to ensure quality is maintained at every lifecycle stage through active participation in the management of the QMS processes based on current legislation and regulations and with a focus on process risk analysis.
Experience Required: More than 3 years of experience in the quality assurance area, specifically process engineering. Preferably at least two years in a medical device and/or pharmaceutical company.
In general:
- Drafting and reviewing, as applicable, documentation related to QMS processes; bilingual English-Spanish or one of both with preference for English.
- Participate in the maintenance of risk analysis of QMS processes.
- Track and maintain key performance indicators (KPIs).
- Frequently inspect the production plant to verify on-site process control and compliance with procedures, as well as train if necessary staff on modifications to be made.
- Organize and convene quality meetings as required to ensure that the effectiveness of the Quality Management System is maintained.
- Identify and propose opportunities for improvement of the Quality Management System.
Your tasks include, but are not limited to:
Related to manufacturing transfer process:
- Transfer from design to production regarding control plans/control methods.
- Training of factory personnel.
- Support to design and construction of test rigs for design and/or manufacturing.
- Change controls relating to in-house and subcontracted manufacturing process (assembly, control).
Related to validation process:
- Writing protocols, participating in the execution and reporting of validations; bilingual English-Spanish or one of both with a preference for English.
- Monitoring the progress of the validation plan and reporting to your manager.
- Preparation of validation maintenance reports and monitoring of equipment, facilities and services; evaluation of trends.
- Validation of clean rooms.
- Validation of ethylene oxide and wet steam sterilisation systems.
- Validation of computerised systems.
- Validation of test methods based on advanced analytical techniques.
- Validation of transport.
Related to risk analysis process:
- Maintenance and updating of facility and process risk analyses.
- Review of current procedures and protocols to ensure alignment with GMP annex 15 on qualification and validation.
Related to calibration process:
- Monitoring the progress of the calibration plan and reporting to your manager.
- Development and updating of calibration procedures.
- Participation in the execution and issuing of calibration reports.
- Control of the spreadsheets of uncertainties, errors, etc.
- Reporting of calibration maintenance status and monitoring of equipment, facilities and services; evaluation of trends.
- Maintaining and updating the risk analysis of the calibration process.
- Equipment inventory control.
- Management of incoming and outgoing laboratory equipment.
In addition:
- Support during audits.
- Collaborate in the preparation of the annual RD report.
- Collaborate in the preparation of annual Section budgets.
- Collaborate with management to achieve the department's objectives.
- All administrative tasks related to the position (digitization and archiving).
- Lead and collaborate in the maintenance of good office conditions, work tools and work environment.
Formal Education:
At least vocational training in instrumentation and control, industrial electronics or similar.
Bachelor's degree in Industrial Engineering (preferably).
Courses or specialization preferred in (not required):
- ISO 17025: Requisitos generales para la competencia de los laboratorios de ensayo y calibración.
- ISO 14644: Clean rooms.
- ISO 11135: Sterilisation of medical devices. Ethylene oxide.
- ISO 14937: Sterilisation of medical devices.
- ISO 14971: Risk analysis for medical devices.
- GAMP5 for the validation of computerised systems
- GMP and validation related regulations.
- Microbiology.
- Metrology.
- English complete professional competence.
- Advanced Microsoft office user.
- Used to work in ERP environments.
Specific Education:
Demonstrable knowledge in:
- ISO 13485: Medical devices.
- Training in legal metrology and/or equipment calibration.
Soft Skills:
- Detail-oriented but also understand the big picture.
- Analytical, proactive and collaborative person.
- Meticulous, efficient, rigorous, dynamic and organized.
- Person with leadership and communication skills
