QA Manager Medical Devices
An exciting opportunity for an experienced QA professional to join an international growing medical device start-up who are about to begin their commercialization journey across the US and Europe. This is an exciting time for this one to be watched by MedTech company.
As a QA Manager, you will take full ownership of the Quality Assurance function maintaining the current QMS and managing product quality supporting regulatory submissions and annual reporting to the notified bodies and FDA. This will be a hands-on role with close interaction with the CTO and CEO.
- Salary: Up to £60K
- Permanent full-time position
- Fully Remote: But should be physically present in the UK or Ireland
- Opportunity to play a key role in a medical device start-up who are destined for major growth
- Maintaining the efficiency of the Quality Management System (QMS) and implementing continuous improvement.
- Working closely with an external consultant on the CE Marking of the new products and FDA Submissions
- Responsible for FDA inspections, notified body audits, and other audits and inspections
- Engineering/Science degree qualification with solid experience within a medical device environment in a similar capacity.
- Qualified as an internal and external auditor
- Knowledge of FDA Quality System Regulation, ISO 13485, ISO 14971, MDD, MDR.
- Experience in writing regulatory device submissions like CE certification, IDEs, and 510(k)
For further details on this QA Manager role apply now with a CV to SomRajendra in Principle or reach out with your LinkedIn profile. All CVs/profiles will be treated in the strictest confidence.
- Medical Devices
- Quality Assurance
- Regulatory Affairs
- Regulatory Submissions
Bank or payment details should never be provided when applying for a job. For information on how to stay safe in your job search, visit SAFERjobs.Report this job
"Office Assistant jobs in London"
'Saved search name'