US Citizen
Green Card
EAD (OPT/CPT/GC/H4)
H1B Work Permit
Corp-Corp
W2-Permanent
W2-Contract
Contract to Hire
Consulting/Contract
UG :- - Not Required
PG :- - Not Required
No of position :- ( 1 )
Post :- 26th Feb 2024
5+ years of experience & demonstrated proficiency in Manufacturing, Regulatory, Process validation & providing ongoing technical support is preferred with evidence of continued self-development.
• Work experience in the Medical Device industry.
• In-depth knowledge of FDA regulations, Industry standards, and guidelines such as ISO 13485 and ISO 14644.
• Experience in control facility, warehouse and cleanroom validation
• Knowledge of Medical Equipment manufacturing processes
• Experience with IQ/OQ/PQ protocols
• Experience with conducting Test method validations.
• Ability to qualify Tooling, Gages and Fixtures
• Knowledge in the areas of Process validation, Statistical process control, Product design & DFMA (Design for Manufacturing & Assembly), Plastic & metallic materials & processing and Applied Statistics
• Knowledge of biocompatibility in medical device industry
• Demonstrated ability to interpret the engineering drawings i.e., GD&T (Geometric Dimensioning &Tolerancing)
• Understanding of Process development & design and Quality Function Deployment
• Excellent Analytic problem solving, Broad business planning, Cross-functional integration skills.
• Demonstrated understanding of Ergonomics and financial analysis skills preferred.
• Excellent Interpersonal / communication skills, Organizational / planning and Project management skills preferred.
• Understanding of Marketing & market research strategies