Commercial Quality Specialist MedTech
· Support Central regional organization to ensure the maintenance of the Quality Systems as per Johnson and Johnson Quality Standards, ISO 9001 Standard and established quality goals
· Ensure efficient information flow and effective communication of all relevant quality matters
· Establish corrective action & preventive actions to mitigate potential or actual noncompliance
· Support Supplier/Distributor Monitoring Program, as applicable;
· Manage the Training Program, as applicable;
· Manage the Field Actions and Product Complaints Management Program, as applicable;
· Record and manage quality issues, escalating serious events to senior management;
· Support hosting and managing of internal and external audits and inspections;
· Support creating inputs for management review process and quality planning;
· Participate in local and regional quality/compliance projects.
- Bachelor’s degree in bioscience, engineering, or business.
- Working experience in the Medical Device Industry in quality/regulatory function.
- Strong collaboration skills and ability to build partnerships internally and externally.
- Excellent written and oral English communication skills.
- Advanced computer skills in MS Office.