QA RA Expert

Position Description and Responsibilities:

*Manage the relationship with the client and all stakeholders 

*Develop project scopes and objectives, involving all relevant customer stakeholders and ensuring technical feasibility

*Create, maintain & approve work plans (as) required by the company

*Coordinate internal resources and third parties/vendors for the flawless execution of projects

*Ensure that all projects are delivered on-time & within scope

*Report and escalate to management as needed 

*QA & RA management (as required by the company) compliant with ISO 13485:2016 / MDD/ EU MDR/ 21 CFR 821, or other as required by the relevant company. Activities may include, (but can be changed per company needs): 

* Assist with regulatory processes.

*Supplier control

*Performance monitoring of Quality goals: Follow-up on production trends, process and final testing. 

* Preparation of management review. 

*QMS monitoring and analysis o Ongoing maintenance of the quality processes (MRB's, ECO's, CAPA, Failure investigations, calibrations etc.). 

*Assist with production processes (e.g., establishment of work instructions, design transfer, DMR and DHR).

*Assist with Design control process and V&V. o Assist with performing internal and supplier Quality System, process and product audits.

Education Requirements:

At least Bachelor’s degree in Engineering or life sciences.

Work Experience Requirements:

*Minimum 5 years Quality Assurance/Regulatory experience as QA/RA team manager in the medical*

device company. 

*Demonstrated knowledge of regulatory issues, and experience interacting with local and international regulatory bodies, such as FDA, European competent authorities & notifies bodies, Health Canada, etc.