QA Manager Medical Devices - Expired
|Job Title||QA Manager Medical Devices|
|Location||Cork City, Cork|
|Job Advertised||about 1 year ago|
QA Manager Medical Devices
Great opportunity for a QA professional to join an international growing medical device start-up who are about to begin their commercialisation journey across the US and Europe. This is an exciting time for this one to be watched 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.
What's in it for you?
- Salary: Up to €80K
- Permanent full-time position
- Opportunity to play a key role in a medical device start-up who are destined for major growth
What would your responsibilities look like?
- 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 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 CV to Som in Principle or reach out with your LinkedIn profile. All CVs/profiles will be treated in the strictest confidence.
For more info contact Som Rajendra Email: firstname.lastname@example.org Ph: 016035075