Position Overview
The Quality Control Specialist manages and records incoming and outgoing quality controls on the finished product. Assists QA in setting up, issuing, storing, distributing and maintaining QMS documents and Technical Files.
Primary Responsibilities
1. Implements the sampling plans issued by QA, manages and records all acceptance and final quality control activities (also in cooperation with external laboratories) in accordance with specific procedures and company control plans.
2. Collects the DHR documents and completes them for the parts under its remit
3. Enters components, semi-finished and finished products into the management system and ensures their quality release.
4. Checks the correct use of the control areas in the warehouse;
5. Checks that the recorded data on the storage conditions of the products in the warehouse are compliant;
6. Provides QA with data on any non-conformities found upon acceptance, in-process and on finished products for the development of process performance indicators as well as for the review of the sampling plans used;
7. Manages and records the maintenance work carried out on the instrumentation in use at the in-house laboratory;
8. Maintains contact with external laboratories in charge of carrying out quality control tests;
9. Opens and manages, with the cooperation of QA, any product/process non-conformities;
10. Together with QA, carries out inspections at the suppliers' premises in order to verify the adequacy of their QMS;
11. Manages the calibration of measuring instruments used in production also with the collaboration of qualified external laboratories;
12. Issues equipment master sheets and scheduled routine maintenance plans and transmits them to OM;
Minimum Requirements
13. Degree in chemistry or equivalent technical and scientific subjects.
14. Experience of 3 years in the medical device field
15. Good knowledge of the general requirements of the UNI CEI EN ISO 13485 standard, the general QMS, the specific rules and regulations of the medical devices sector as well as of the company's quality control procedures.
16. Good knowledge of sampling procedures and statistical processing;
17. Good knowledge of the type and technical, qualitative and functional characteristics of in-house manufactured medical devices.
18. Good knowledge of internal control procedures, DMRs, the company's traceability system and the recording of production and control phases of products manufactured in-house and at external suppliers;
19. Good knowledge of the English language