Effective monitoring and maintenance of Quality Management System as per ISO 13485.
Supporting introduction of new product & processes by effective process validation
Incoming Inspection of components and on time release to production.
Ensure that the adequate Process Control in place and on time Production Batch release.
Calibration of Instruments and Qualification of equipments.
Support Complaint Handling Activities.
Assists in internal audits, as a means of evaluating the effectiveness of the established Quality Systems and Good Manufacturing Practices.
Ensuring that Change Control process is followed for all material, process & product related changes.
Ensure the product quality and process capability through Statistical Quality Control (SQC) and Statistical Process Control (SPC).
Clean Room maintenance and controls at par with worldwide standards.
Experience with QA/QC activities of collagen materials Combination products, Drug device combination, and Advance wound care.
Exposure to EU GMP quality system and having exposure to USFDA inspection/audits is mandatory.
Knowledge in handling Medical Device of all classes as per EMEA and USFDA.
Mandatory experience worked in Clean room Class 10,000, 1000, 100.
To study and understand the various procedures of Medical Device testing, Quality Control techniques, FTA, FMEA
Expertise in the Testing and finished product release procedure.
Very good in documentation practices making SOPs, Developing In-house Testing Techniques.
Excellent record keeping and computer skills especially well-versed with Microsoft office.
Basic understanding of physico-chemical testing, biological testing for full characterization, Clinical comparability pathway, develop investigational medical product.