Director, Quality

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Job Function:
Quality

Job Sub Function:
Multi-Family Quality

Job Category:
People Leader

All Job Posting Locations:
Alajuela, Costa Rica, Santa Clara, California, United States of America

Job Description:

Johnson & Johnson is hiring for a Director, Quality to join our team located in Shockwave Medical Costa Rica.

Position Overview:

The Director of Quality is responsible for the administration, supervision, and development of the Quality group in Costa Rica.

They are expected to provide leadership for the organization's quality engineering, quality control, quality systems and document control, calibrations, and risk management program.

The Director of Quality d evelops and implements procedures and systems to assure Shockwave Medical, Costa Rica complies with applicable regulatory standards such as:



* ISO 13485 - Medical Devices - Quality Management Systems


* 21 CFR 820 and 21 CFR 803


* ISO 14971 Application of Risk to Medical Devices


* Council of the European Communities Directive 93/42/EEC - Medical Device Directive


* Current Good Manufacturing Practices (CGMP) Quality Systems Regulation


* EU MDR - European Medical Device Regulation (MDR)


* MDSAP and other relevant geography regulations


* CMDR - Canadian Medical Devices Regulations

Essential Job Functions

Site Establishment


* Is directly responsible for the implementation of a Quality Management System for the Shockwave CR site and document control functions for the Shockwave CR site


* Interfaces with Santa Clara (headquarters) personnel to ensure continued compliance to overall corporate and Costa Rica site specific requirements


* Coordinates with the Shockwave-Santa Clara site to support the transfer and validation of manufacturing lines at the Shockwave-CR site

Compliance


* Acts as the Quality Representative, and host, for external Quality audits (eg: FDA, BSI, JJRC)


* Plans and executions for Management Reviews for the Shockwave CR site


* Ensures that product and process changes are approved by Santa Clara personnel prior to implementation at the Shockwave CR site


* Manages, executes, and makes impr...