Sr. Quality Engineer (Fda Regulated)
By Advanced Clinical At Los Angeles Metropolitan Area, United States
Approval of change management activities.
Participate as requires in Audits and Management Reviews
Lead/ participate in quality systems and compliance improvements that results from all Audits, management Reviews and any other NCR/CAPA system indicators.
Knowledge of 21 CFR 820, ISO 13485, ISO 14971 and EU MDR, and CE regulatory requirements
Develop Process Failure Mode and Effect Analysis (pFMEA) to manage process risks.
Minimum 5+ years work experience in quality, manufacturing, or engineering.
Qa Engineer With Medical Or Fda
By Peritus - A Colina Tech Group At Alameda, CA, United States
ØCandidate should have experience in mobile App testing and device testing preferably in life science domain.
ØProgramming skills to write test scripts in typescript/JavaScript and Appium.
ØGood knowledge in SQL queries and basic knowledge in writing stored procedure.
ØKnowledge in HP ALM, JIRA, Confluence, Browser stack is required.
ØGood to have knowledge in API testing, Web driver IO and mobile automation.
ØHands on experience in version controlling like GitHub.
Sr. Quality Engineer (Fda Regulated)
By Advanced Clinical At San Francisco Bay Area, United States
Approval of change management activities.
Participate as requires in Audits and Management Reviews
Lead/ participate in quality systems and compliance improvements that results from all Audits, management Reviews and any other NCR/CAPA system indicators.
Knowledge of 21 CFR 820, ISO 13485, ISO 14971 and EU MDR, and CE regulatory requirements
Develop Process Failure Mode and Effect Analysis (pFMEA) to manage process risks.
Minimum 5+ years work experience in quality, manufacturing, or engineering.
Fda Investigators And Reviewers
By Pharmatech Associates, a USP company At San Francisco, CA, United States
Conduct gap assessment of quality management systems and provide prioritized remediation recommendations
Provide interpretation of GxP requirements for novel therapeutics
B.S. life sciences and 10 years’ relevant experience
FDA Experience is required (investigator or reviewer)
Expert knowledge of current FDA, ICH, and USP laws, regulations, guidances and expectations.
Ability to lead projects, where required, manage work to a defined scope of work and meet crucial timelines
Regulatory Affairs Fda Consultant
By Arcondis Group At Texas, United States
Proficiency in project management and ability to handle multiple projects simultaneously.
In-depth knowledge of FDA regulations, guidelines, and submission processes for both medical devices and pharmaceutical products.
Excellent written and verbal communication skills.
Serve as the main liaison between clients and FDA, facilitating effective communication and swift resolution of issues.
Keep abreast of changes in FDA regulatory guidelines, standards, and policies, interpreting their implications for client projects.
Advise clients on the clinical data necessary to support device and drug approval, including the design and review of clinical studies.
Fda Videographer Jobs
By Media Fusion At , Silver Spring, 20903, Md
Assist in the development of scripts and storylines to understand animation requirements
Proven experience as an animator
Knowledge of 2D/3D, stop motion and computer-generated animation
A creative storyteller with presentation abilities
Create and develop multimedia (audio/video) digital content for social media, web and other FDA projects
Plan video shoots and scout locations when possible