Quality Assurance Specialist

QA & RA Team Leader

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
•   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.
• 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 interfacing with local & international regulatory bodies, such as FDA, European competent authorities & notified bodies, Health Canada, etc. 

Experience of routine QA/QC activities: CAPA, MRB, ECO, RMA, SCAR