Senior Quality Engineer
We are seeking a Senior Quality Engineer to join our medical device startup company.
About the Role
The successful candidate will report to the Senior Quality Manager and work across all stages of development, manufacture, and commercialisation.
You will support the Senior Quality Manager with maintaining the Quality Management System, working with R&D, manufacturing and regulatory teams to ensure the device meets user, regulatory and ISO 13485 requirements.
Key Responsibilities
* 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
Requirements
To be considered for this role, you will have:
* A 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.)
* Project planning, communication and writing skills
* A 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 sterilisation experience preferred
* Process validation experience preferred