Design Control Engineer
Responsibilities
Support the maintenance and organization of the Design History File (DHF) documentation.
Assist in completing documentation required for product releases in compliance with FDA, CE, ISO, and internal procedures.
Provide administrative support for design control activities throughout the product development lifecycle.
Support documentation related to software validation and traceability.
Assist in preparing documentation for audits and regulatory submissions.
Ensure documentation is accurate, complete, and properly filed in internal systems.
Requirements: BSc in Biomedical Engineering, Biotechnology, Life Sciences, or a related field.
1+ years of experience in quality management / regulated medical device environments.
Ability to manage multiple documents and tasks simultaneously.
Strong computer skills.
Proactive attitude and willingness to learn.
Strong organizational and communication skills and high attention to detail.
Prior experience in documentation/administrative roles - an advantage.
This position is open to all candidates.