MillenniumSoft Inc · 4 months ago
Senior Staff Quality Engineer (Strong Medical Device Exp) Onsite
San Diego, CA
Contract
Onsite
Senior Level, Lead/Staff
10+ years expMillenniumSoft Inc is seeking a Senior Staff Quality Engineer with strong medical device experience to lead a project aimed at improving the quality and compliance of the Dispensing Implementation process. This role involves evaluating regulatory requirements, leading cross-functional efforts, and ensuring adherence to quality processes to prepare for external regulatory agency inspections.
Staffing & Recruiting
No H1B
U.S. Citizen Only
Responsibilities
Evaluating the Dispensing Implementation process against regulatory requirements associated with CFR 820.200 and international regulatory requirements
Leading a cross-functional effort to develop and execute the plan to improve the compliance state of the process
Communicate weekly status to the Quality and SDS leadership teams
Compliance to all service record documentation requirements
Adherence to BD Inspire Quality Processes
Driving effective and efficient installation and implementation execution
Quality Engineering is responsible for product and service quality evaluation and control. Works cross-functionally in the development and/or maintenance of products or services
Qualification
Required
Bachelor's degree in a relevant degree field (engineering)
Minimum 10 years' experience in a Quality role in FDA regulated environments
Demonstrated experience with the Quality requirements for installation of medical devices
Extensive demonstrated history completing quality/compliance improvement projects in an FDA regulated environment
Attentiveness to details with strong organizational skills
Ability to work proactively and independently
Ability to multi-task and efficient in time management
Excellent verbal communication and interpersonal skills with the ability to work in a team environment
Proficiency in Excel, Word, and other desktop/general business systems
Preferred
Demonstrated experience with installation of medical devices with embedded software
Quality Engineering Certification (ASQ) or equivalent
Company
MillenniumSoft Inc
Hire us to hire for you Staffing is not a straightforward activity.
51-200 employees
Funding
Current Stage
Growth StageLeadership Team
Sailaja Mashetty
Partner - Customer Sucess
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