Us Citizen
Green Card
EAD (OPT/CPT/GC/H4)
Corp-Corp
Consulting/Contract
UG :- - Not Required
PG :- - Not Required
No of position :- ( 1 )
Post :- 9th Mar 2021
MAIN PURPOSE OF ROLE
This position is responsible for executing and maintaining software quality engineering methodologies and providing quality engineering support for software utilized throughout the division.
MAIN RESPONSIBILITIES
• Develop and conduct training of company personnel for the divisional software development and validation program.
• Work with Design and Manufacturing Engineering in the completion of system/software requirements and other verification and validation processes.
• Create and execute or direct software validation protocols traceable to system/software requirements.
• Implement solutions for controlling code and administer Code Control and Software Event/Defect Tracking software systems.
• Assist in the completion and maintenance of risk analysis, focused on software related risks.
• Design and implement various product and process improvement methodologies (ie Six Sigma and Lean Manufacturing).
• Apply sound, systematic problem solving methodologies in identifying, prioritizing, communicating, and resolving issues.
• Software scoping and Part 11 audits.
• Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
• Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
QUALIFICATIONS
Experience Details
Ability to travel approximately 5-25%, including internationally (when permitted again)