The ideal candidate will have a Bachelor's degree in Engineering (Electrical, Mechanical, or Biomedical preferred) or a related technical discipline.
Key Responsibilities:
* Liaise with service/repair teams and R&D to improve product reliability and reduce recurring faults.
* Maintain and improve the Quality Management System (QMS) in compliance with ISO 13485, MDR, GMP, and other applicable regulations.
* Develop and maintain essential technical documentation such as Work Instructions (WIs), Test Instructions and Validation Protocols, Job Cards, Device History Records (DHRs).
Technical Documentation
* Ensure documentation is aligned with design specifications, regulatory requirements, and production needs.
* Conduct internal audits and coordinate external audits (e.g., notified bodies, regulatory agencies).
Change & Configuration Management
* Lead and document Engineering Change Requests (ECRs) and Engineering Change Orders (ECOs).
* Maintain accurate Bill of Materials (BOMs), drawings, and revision control.
Team & Cross-Functional Collaboration
* Lead and support technical staff, providing mentoring and development.
* Collaborate with Regulatory, Production, Sales, and R&D teams to ensure quality and technical alignment across the business.
Qualifications & Experience:
* In-depth knowledge of ISO 13485, MDR, and QMS principles.
* Demonstrated experience in fault finding and root cause analysis.
* Strong technical writing skills with experience creating and managing technical documentation.
* Experience managing suppliers and leading change control processes.