UroMedTech is seeking a detail-oriented Quality Engineer to drive excellence in both Operational Quality Control and Design Verification. You will be a key guardian of product safety for our medical devices and sterile consumable kits, ensuring every unit meets stringent international regulatory standards and our internal Quality Management System (QMS).
Key Responsibilities
Operational Quality Control (QC):
- Manage Incoming Quality Control (IQC) and final product verification for devices and sterile kits.
- Oversee critical infrastructure, including production/storage environment monitoring and equipment calibration.
- Identify and document non-conformances (NCR) and deviations, assisting in root cause analysis and CAPA.
Design Verification & Validation (V&V):
- Develop and execute hardware/system testing protocols to verify product performance and reliability.
- Document technical reports and ensure the Design History File (DHF) reflects accurate testing outcomes.
- Participate in Risk Management (ISO 14971) activities, specifically verifying the effectiveness of risk control measures.
Quality Systems & Compliance (QA):
- Maintain and update SOPs and Work Instructions to stay aligned with ISO 13485 and FDA 21 CFR 820.
- Support change request justifications to ensure product modifications do not compromise safety or compliance.
- Collaborate cross-functionally with R&D and Operations to resolve quality bottlenecks.
Requirements
- Bachelor's Degree or Diploma in Biomedical, Mechanical, or Mechatronics Engineering.
- Fresh graduates are welcome to apply relevant internship experience in a regulated industry is a plus.
- Basic understanding of testing methodologies (Functional, Reliability, or Environmental testing).
- Familiarity with MedTech standards (ISO 13485, ISO 14971, FDA).
- Strong problem-solving mindset and the ability to communicate technical findings clearly to diverse teams.
