Senior Quality Engineer
We are seeking a Senior Quality Engineer to join our team at {company}.
About the Role:
This is an exciting opportunity for a highly motivated and experienced Senior Quality Engineer to join our medical device startup company.
Main Responsibilities:
* Support the Senior Quality Manager in maintaining the Quality Management System.
* Work with R&D, manufacturing, and regulatory teams to ensure devices meet user, regulatory, and ISO 13485 requirements.
* Develop quality plans, programs, and procedures for commercialization.
* Ensure all work is carried out in compliance with Quality, Regulatory, and company policies and systems.
Key Skills and Experience:
* Bachelor's degree in a relevant Engineering or Science field.
* 5 years' experience in the medical device industry or equivalent higher-level postgraduate study (masters or Ph.D.).
* Strong project planning, communication, and writing skills.
* Sound understanding of engineering fundamentals.
* Knowledge of medical device quality & regulatory systems and medical device directives (ISO 13485 and FDA CFR 820) essential.
* Cleanroom and sterilization experience preferred.
* Process validation experience preferred.