At Rob Surgical we are looking to hire a Process Engineering Quality Assurance Technician to join our Quality team and support the continuous improvement and validation of our manufacturing and quality processes.
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About us
We are a healthtech company specialized in the development of advanced robotic systems for high-precision minimally invasive surgery. Founded in 2012 as a spin-off from UPC and IBEC, our mission is clear: to make robot-assisted surgery more accessible, precise, and efficient worldwide.
What will your mission be?
As aProcess Engineering QA Technician, you will play a key role in ensuring the effectiveness of our Quality Management System (QMS) by supporting the validation master plan, calibration program, and process quality activities.
You will work closely with product managers, project managers, developers, and manufacturing teams to ensure quality and regulatory compliance across the entire product lifecycle.
Your main responsibilities will include:
Quality Management System
* Drafting and reviewing documentation related to QMS processes.
* Participating in the maintenance of risk analyses for QMS processes.
* Monitoring and maintaining quality KPIs.
* Conducting regular inspections in the production plant to verify process control and compliance with procedures.
* Organizing and participating in quality meetings.
* Identifying and proposing opportunities for continuous improvement within the QMS.
Manufacturing transfer
* Supporting the transfer from design to production, including control plans and control methods.
* Training manufacturing personnel when required.
* Supporting the design and construction of test rigs for design and manufacturing validation.
* Managing change controls related to internal and subcontracted manufacturing processes.
Validation activities
* Writing validation protocols and reports.
* Participating in validation execution and monitoring progress of the validation plan.
* Preparing validation maintenance reports and monitoring equipment, facilities, and services.
* Participating in validations related to:
* Clean rooms
* Ethylene oxide and wet steam sterilization systems
* Computerized systems
* Analytical test methods
* Transport validation
Risk analysis
* Maintaining and updating facility and process risk analyses.
* Reviewing procedures and protocols to ensure alignment with GMP Annex 15.
Calibration management
* Monitoring the calibration program and reporting progress.
* Developing and updating calibration procedures.
* Participating in calibration activities and issuing calibration reports.
* Managing laboratory equipment inventory and tracking uncertainties, errors, and trends.
Additional responsibilities
* Supporting internal and external audits.
* Collaborating in the preparation of annual R&D reports and department budgets.
* Supporting administrative tasks related to documentation, digitalization, and archiving.
* Contributing to maintaining an organized and efficient work environment.
What are we looking for?
* Bachelor's degree in Industrial Engineering is highly valued.
* Experience level: 3+ years of experience
* Experience in medical devices and/or pharmaceutical industry is highly valued.
* Professional working proficiency in English.
* Advanced Microsoft Office user.
* Experience working with ERP environments.
Valuable knowledge
Experience or training related to:
* ISO 17025 – Calibration laboratories
* ISO 14644 – Clean rooms
* ISO 11135 / ISO 14937 – Sterilization of medical devices
* ISO 14971 – Risk management for medical devices
* GAMP5 – Validation of computerized systems
* GMP and validation regulations
* Metrology or microbiology
We are looking for someone who is...
* Detail-oriented but able to understand the big picture.
* Analytical, proactive, and collaborative.
* Meticulous, organized, and efficient.
* A strong communicator with teamwork.
What do we offer?
* Full-time permanent contract.
* Salary aligned with profile and experience.
* Flexible working hours.
* Monthly fruit and vegetable box
* Opportunity to work on cutting-edge surgical robotics technology.
* Professional development in a highly innovative and regulated environment. xohynlm
* A dynamic and collaborative team where your work has real impact on patients' lives.