26 applicantsPosted by Agency
Infojini Inc ยท 2 days ago
Senior Quality Specialist
Los Angeles, CA
Contract
Onsite
Mid Level
3+ years exp
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Hiring Manager
Vaibhav Mittal
Insider Connection @Infojini Inc
Responsibilities
Provide continuous and rigorous assessment of NC activities and documentation to assure compliance with the Quality Management system, FDA regulations, ISO 13485, and Medical Device and IVD requirements through the review of NC records at critical phases.
Provide guidance, support and mentorship to NC process owners regarding the NC process, best practices, record content, and software tools.
Support MRB and senior leadership with metrics and reporting on critical aspects regarding the health of the NC process.
Participate and coordinate MRB activities and perform walk through internal audits throughout the site.
Support the continuous improvement of procedures, software, and training programs.
Provide guidance in interpreting governmental regulations, agency guidelines and Thermo Fisher internal policies in general and specific to NC to assure compliance.
Support internal and external audits and inspections for NC records and processes and other roles as needed.
Perform other related duties as assigned.
Qualification
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Required
Bachelor's degree and 3+ years or Master's degree with 1+ years in a quality, manufacturing, or leadership role (preferably in Quality Management Systems)
Preferred
Experience working with CAPA, complaints, and nonconformances
Experience in medical device, pharmaceutical, IVD and/or a comparable regulated environment
Influence management skills; ability to work constructively across all functions of the organization as well as with external customers, notified bodies, regulatory agencies, and competent authorities
Project management skills
CAPA documentation systems experience (e.g. CATSWeb, MasterControl, Trackwise,, etc.)
Experience reviewing CAPA, complaint, nonconformance documentation (preferably as an independent reviewer)
Strong written and verbal communication skills
Ability to educate people in the CAPA program
Experience with quality tools and process improvement techniques
Knowledge of effective root cause investigation, corrective and preventive action planning and execution and verification of effectiveness techniques
Strong analytical and decision making skills
Understanding of FDA regulations (21 CFR 820, 210/211 as applicable and Part 11), ISO 13485, and CAPA requirements in general
Company
Infojini Inc
Founded in 2006. Infojini, Inc. has provided IT Services to various Government and Fortune 1000 clients globally.
501-1,000 employees
H1B Sponsorship
Infojini Inc has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Trends of Total Sponsorships
2023 (10)
2022 (5)
2021 (6)
2020 (22)
Funding
Current Stage
Late StageRecent News
Baltimore Business Journal
2023-11-04
Company data provided by crunchbase
