Lead regulatory inspections (e.g. FDA) and customer audits. This includes pre-audit/inspection preparations, portraying professional approach during the inspection/audit conduct and providing responses to and closure of resultant findings/process gaps in a timely manner.
Manage Healthcare QMS and all Regulatory Activities such as Customer complaints, Recall, and Post-market vigilance reporting
Ensure software validation protocols and associated validation runs are in compliance with FDA guidance and Software Validation Principles, FDA 21 CFR Part 11 requirements and various regulatory requirements.
Manage internal audits per established schedule.
Assist in establishing and maintaining the effectiveness of the quality management system as a whole
Assist in creation and ongoing review of QMS documentation, highlighting any gaps encountered with reference to GCP E6, 21 CFR Part 11 and other applicable regulatory requirements.
Manage all Vendor Management activities such as Vendor Evaluation/re-evaluations, Vendor audits, Vendor file management and updates. Manage Document and Change Control, Deviation, Non-conformances and CAPAs as needed.
Manage the overall quality and provide guidance and constraints to the teams.
Approve quality documents (including validation protocols and reports) and authorize releases and deviations on behalf of the Sr. RA/QA Manager.
Work with and provide necessary guidance to all the departments in creating, revising, implementing, and
Approve software/product releases for customer use.
Manage Healthcare QMS and all Regulatory Activities such as Customer complaints, Recall, and Post-market vigilance reporting.
Mentor and develop subordinates
Technology doesn't change the world. People do.
As a technology staffing firm, we can't think of a more fitting mantra. We're extreme believers in technology and the incredible things it can do. But we know that behind every smart piece of software, every powerful processor, and every brilliant line of code is an even more brilliant person.
Leader among IT staffing agencies
The intersection of technology and people — it's where we live. Backed by more than 65 years of experience, Robert Half Technology is a leader among IT staffing agencies. Whether you're looking to hire experienced technology talent or find the best technology jobs, we are your IT expert to call.
We understand not only the art of matching people, but also the science of technology. We use a proprietary matching tool that helps our staffing professionals connect just the right person to just the right job. And our network of industry connections and strategic partners remains unmatched.
Apply for this job now or contact our branch office at 888-490-4429 to learn more about this position.
All applicants applying for U.S. job openings must be authorized to work in the United States. All applicants applying for Canadian job openings must be authorized to work in Canada.
© 2019 Robert Half Technology. An Equal Opportunity Employer M/F/Disability/Veterans.
$44.65 - $51.70 /Hour
Engineering & Aerospace, IT & Technical, Creative & Design