Senior Quality Engineer
We are seeking a Senior Quality Engineer to join our team at {company}, a medical device startup company.
Key Responsibilities:
* Support the Senior Quality Manager in maintaining the Quality Management System.
* Collaborate with R&D, manufacturing, and regulatory teams to ensure the device meets user, regulatory, and ISO 13485 requirements.
* Provide quality support during in-house manufacture and lot release.
* Develop quality plans, programs, and procedures for commercialisation.
* Ensure all work is carried out in compliance with quality, regulatory, and company policies and systems.
* Review, analyse, and report on quality discrepancies related to product design and manufacture.
* Liaise and support OEM contractors/vendors during the manufacture of components.
* Support during regulatory agency audits, including FDA and Notified Body, and aid in the preparation of non-conformity responses as necessary.
Requirements:
* Bachelor's degree in a relevant Engineering or Science field.
* 5 years of experience in the medical device industry or equivalent higher-level postgraduate study (master's or Ph.D.).
* Project planning, communication, and writing skills.
* A sound understanding of engineering fundamentals.
* Knowledge of medical device quality and regulatory systems and medical device directives (ISO 13485 and FDA CFR 820) is essential.
* Cleanroom and sterilisation experience is preferred.
* Process validation experience is preferred.