- Communication skills
- ISO 13485
- FDA regulations
Roles & Responsibilities:
Process Validation experience, who will work with Cross Functional Team members at customer site to get the alternate new material qualified and released for production.
Interpret standards and FDA requirements for material qualifications
Experience in Preparation of URS, FAT/SAT, Protocol documents for listed equipment's and processes
Establish test protocols driven by national and international standards and regulatory requirements.
Facilitate the testing of new processes to verify product reliability.
Should have worked in medical device manufacturing
Provides technical input for projects using the application of FMEA's, risk mitigation, plant validations DOE's' and other experiments and investigations as assigned.
Working knowledge of Validations, IQ, OQ, PQ, and DOE's is desirable.
Operate various test equipment, interpret test data, and report results for each validation/verification
Formulates, reviews, and implements policies and procedures relating to Process Validation and process control as appropriate.
Coordinates machine and process capability studies, analyses the data, and submits recommendations.
Need to have strong communication skill to interact with customers and vendors
Experience in the application of FMEA, risk mitigation and CAPA
Should have strong knowledge in ISO 13485, EU-MDR and material selection process