Quality Assurance Specialist
Job Summary
We are seeking a Quality Assurance Specialist to provide quality assurance support to our Manufacturing Operations. This role involves resolving quality-related issues, improving product quality, and investigating customer complaints.
-----------------------------------
About the Role
This position requires effective management of non-conformities, including Chemistry products and Disposable machines. The successful candidate will also be responsible for supporting the Correction and Preventive Action (CAPA) process, ensuring timely implementation of corrective actions, and maintaining accurate audit working papers and files.
* Manage NC's process for Chemistry products and Disposable machines.
* Support CAPA's process and follow-up on corrective actions.
* Investigate product complaints and implement corrective/preventive actions as needed.
-----------------------------------
Responsibilities
The Quality Assurance Specialist will participate in preparation of Process Failure Mode and Effects Analysis (PFMEAs), evaluate opportunities for improvements to the operation of the QA department, and support periodic review of department internal control procedures.
* Participate in PFMEA preparation.
* Evaluate opportunities for improvements.
* Support periodic review of internal control procedures.
-----------------------------------
Qualifications
To be considered for this role, you should possess a Master degree in Chemistry or Pharmacy, with knowledge of ISO 13485, Medical Devices Directive (MDD) 93/42 / EEC, and applicable standards required by the European and non-European market.
* Master degree in Chemistry or Pharmacy.
* Knowledge of ISO 13485 and MDD 93/42 / EEC.
* Minimum knowledge of single-use medical devices.
Additionally, you should have experience in audit activities, good interpersonal and professional communication skills, and a minimum of one to three years related experience.
* Experience in audit activities.
* Good communication skills.
* Minimum one to three years related experience.
We offer flexible work arrangements and a supportive team environment. If you are passionate about quality assurance and have the necessary qualifications and experience, we encourage you to apply for this exciting opportunity.